DEVICE: Platinum (B679SLP4H0)

Device Identifier (DI) Information

Platinum
P4H
In Commercial Distribution
SLP4H
SUMMUS MEDICAL LASER, LLC
B679SLP4H0
HIBCC

1
621560338 *Terms of Use
Light weight (~2.5 Kg.) and portable therapeutic medical laser device (measuring ~258.65mm x 238.43m x 88.86mm) disc shaped, indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments (Continuous Wave - CW power 28W and Intense Super Pulse - ISP power 30W) are in the form of non-ionizing radiation in which the invisible light wave doses (810nm +/- 10nm, 915nm +/- 10nm, 980nm +/- 10nm) and visible light wave aiming beam (650nm +/- 20nm) are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60409 Musculoskeletal/physical therapy laser, professional
An electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ILY Lamp, Infrared, Therapeutic Heating
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 35 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

10ab7ef1-5bda-4fa1-8a2d-9a7d4111e10e
July 23, 2024
43
October 27, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
(770) 428-4909
mariettachiropractic@gmail.com
(704) 689-8622
k8hoffmandc@gmail.com
(410) 535-2590
dexallen@yahoo.com
(845) 362-0100
drjhorowitz@gmail.com
(703) 997-9776
dr.gloor@clarendonanimalcare.com
(202) 974-6621
csimon@releasept.com
(843) 754-4231
Wbr215@gmail.com
(678) 333-3751
drkristina@elitetotalwellness.com
(561) 391-5331
Drabdelfattah4@gmail.com
(919) 606-2511
Dr.tracy@carolinatmj.com
(951) 817-9815
drrichter@prodigy.net
(651) 735-1585
Tdresen@msn.com
(478) 988-3200
info@drbraswelldds.com
(440) 655-8799
cloudyrose@hotmail.com
(919) 917-2970
info@luxemedconcierge.com
+3864198897
info@fizian.si
(503) 222-1865
brad@evolutionhealthcarefitness.com
(540) 659-8140
tsagahvet@yahoo.com
(724) 222-8322
drwano@verizon.net
(503) 975-5531
drcoryharkins@gmail.com
(717) 299-9600
shayne_bushong@yahoo.com
(631) 476-0400
rooseveltmail@aol.com
(786) 353-4325
info@353heal.com
(330) 494-3190
manager@animalcareohio.com
(856) 206-9560
drsandoz@comcast.net
(760) 773-3595
reachtonynow@yahoo.com
(319) 367-5511
alisha@hometownvetcare.com
(760) 773-3595
powerofchiropractic@hotmail.com
(815) 345-9544
Office@northernlakesequine.com
(352) 332-1992
info@Chiro352.com
(240) 687-1414
drcarr@marylandexotics.com
(904) 733-7020
dedenfield@gmail.com
(904) 389-1010
kramarich@riversidespine.com
(954) 254-1097
info@aspiretotalwellness.com
(484) 357-5184
dennis.dougherty@sluhn.org
(864) 223-2663
drchuck123@gmail.com
(904) 278-0600
ponchopup74@gmail.com
(614) 205-6331
drscotthaggerty@gmail.com
(954) 254-1095
info@aspiretotalwellness.com
(703) 533-5555
drfuselier@pwcmc.com
(615) 791-9148
lpfeffer@littlehouseanimalhospital.com
(309) 681-8888
noelliudds@gmail.com
(954) 942-8402
sandscc@bellsouth.net
(626) 332-0638
jkurumada@eastsidechristian.org
(256) 881-1575
gaillynnbriggs@gmail.com
(603) 679-8100
bodywise.llc@gmail.com
(843) 357-9617
admin@waccamawchiropractic.com
(419) 921-5644
toplineequinechiro@gmail.com
(704) 459-4848
drh@dallashumble.com
(402) 389-3356
emily@lonetree.vet
(904) 608-0653
agapechirojax@gmail.com
(410) 758-0738
mdricex5@aol.com
(954) 942-8402
drsands@sandschiro.com
(716) 650-7246
wynpainrelief@gmail.com
(318) 395-2273
jonesboroanimalclinic@gmail.com
(765) 629-2134
sue@jackmananimalclinic.com
(615) 790-6363
teamhealth@wellnesscenteroffranklin.com
(937) 236-4207
oldtroypikevetclinic@gmail.com
(615) 217-8624
ltccboro@gmail.com
(678) 468-7746
sabledds@bellsouth.net
(812) 699-0389
gerrrencullisondc@gmail.com
(904) 278-0600
info@sandypawsanimalhosptial.com
(803) 356-1350
lexspinal@yahoo.com
(919) 750-0661
info@drchristianchiropractic.com
(574) 231-9205
bgbiggers@comcast.net
(608) 255-1239
yellowlabone@gmail.com
(616) 791-2011
general@schmittsah.com
(513) 821-1101
iah@lewisanimalhospital.com
(603) 945-1995
info@nhregenerativecenter.com
(610) 617-7300
citylinechiropractice@gmail.com
(864) 297-6270
drdesimone@evergreenfamilychiropractic.com
(412) 882-3070
Barbara.hull@verizon.net
(864) 288-8593
Info@carolinahealthinnovations.com
(843) 839-0807
Jkwright91@gmail.com
(786) 677-1838
Santosanimalclinic@gmail.com
(510) 652-5835
Staff@claremontvet.com
(219) 462-5901
Mcafee.animal@frontier.com
(561) 708-5700
Info@chiropalmbeach.com
(678) 570-6146
theresa.harris@integratedinjury.com
(832) 622-1515
DrL@thrivemedicineclinic.com
(814) 233-9251
dr.vought@dvm.com
(402) 826-2497
cretevetclinic@gmail.com
(973) 248-5757
kristiesteeledvm@gmail.com
810-664-2233
Tracythorpe@gmail.com
(678) 803-0236
actiehealthcarerehab@gmail.com
(734) 369-2032
Swilkinson13@gmail.com
(410) 867-0770
vickilin@verizon.net
(410) 820-7377
rthomps345@gmail.com
(704) 482-0135
brad@ncchiroplus.com
(615) 595-7749
omaima@creativity-medical.com
(843) 681-7777
drbradfraum@fraum.com
(684)292-7756
drlowery@blueridgefamilychiropractic.com
(770) 926-9495
drkal@me.com
(615) 595-7749
global@staronic.com
(770) 367-2863
drjim@lifetimesmiles.com
(712) 653-2607
manningvets@gmail.com
(631) 366-0003
njtail@verizon.net
(615) 444-4422
allencraigdvm@gmail.com
724-586-5858
drjdcnd@zoominternet.net
(815) 263-1360
contactgoldorado@gmail.com
(812) 867-7335
rstonedvm@gmail.com
(850) 479-2700
nealclinicinsurance@gmail.com
(386) 740-0963
ashley@volusiavetservices.com
(859) 268-1780
cdonworth@gmail.com
(937) 526-4900
brunsanimalclinic@hotmail.com
(859) 987-2883
kicourt@aol.com
(818) 450-4164
hanteakoh@gmail.com
(972) 353-9672
clint@toomyemail.com
(843) 800-0413
drsamcurtis@yahoo.com
(949) 795-9196
info@armstrongfit.com
(334) 737-6840
drrob@genesishealthauburn.com
(810) 329-4100
riverviewvetstaff@gmail.com
(650) 279-4676
drlisa@lisadevlin.com
(319) 366-6441
abrahamsequine@aol.com
(215) 736-3338
ckura@doxierescue.com
(858) 200-7692
infor@drwarde.com
(713) 522-9814
djmitchell@naturalheathhouston.com
(803) 327-6155
carinnacpk@gmail.com
(541) 618-0090
ebah@eastbendvet.com
(559) 256-5200
jealand@spoc-ortho.com
(515) 231-5053
doctammyk@gmail.com
(832) 545-6775
jhassler@rocketball.com
(989) 297-7215
guilebar@gmail.com
(989) 871-3521
petclincbiloxi@gmail.com
(317) 595-9620
drfuselier@pwcmc.com
(904) 794-4002
Accounting@matanzasrivervet.com
(651) 484-3331
mvhteam@mnvet.com
(770) 594-2233
drdna@adlerchiro.com
(810) 531-0346
willtop2121@gmail.com
(408) 890-1590
helenbee@yahoo.com
(615) 595-7749
Jking@summuslaser.com
(718) 680-1117
cyberdent@mac.com
(724) 543-4171
sjmsgu@gmail.com
(256) 593-9083
johnwallace5353@att.net
(469) 740-5517
drlopezchiro@gmail.com
(208) 229-2500
kathybecker2011@gmail.com
(209) 368-5166
info@lodivethospital.com
(770) 988-8884
drsaxon@bellsouth.net
(615) 595-7749
ehliao@yuanyu.tw
(989) 772-1609
msppaindoctor@msn.com
(704) 938-1400
drsandy@caroline.rr.com
(336) 774-1624
grayld@bellsouth.net
(724) 776-7387
info@gsveterinaryhospital.com
(440) 557-5011
info@advancedmmc.com
(678) 992-5770
dmeary@comcast.net
(717) 838-2643
salliugur@gmail.com
(770) 832-1640
clydedc@yahoo.com
(704) 966-0816
pannelwellnesssolutions@gmail.com
(817) 913-7091
a.willms5@gmail.com
(704) 243-1010
drkylebjonesdc@gmail.com
(704) 236-5747
drleevang@gmail.com
(803) 739-9333
reid@petsinc.org
(843) 945-4087
chadbonedc@gmail.com
(984) 212-3788
drshepard@luxemdconcierge.com
(404) 552-3690
thepaylessdoctor@gmail.com
(336) 223-8644
ironwillvets@gmail.com
(574) 286-8413
gorkaj75@gmail.com
(510)652-5835
Staff@claremontvet.com
(850) 784-7800
pmclure@gmail.com
(253) 797-1919
kristinclose10@gmail.com
(210) 342-7387
northstaranimalhopspital@gmail.com
(708) 494-4015
Dradambezanis@yahoo.com
(843) 817-7404
luckie.mark@gmail.com
(815) 266-9167
jafrank23@hotmail.com
(908) 887-0172
drmike@RSHChiro.com
(912) 541-1635
Chiropracticgrgasiecki@yahoo.com
(303) 994-0301
jon.denning@outlook.com
(404) 974-5462
sherraconde@gmail.com
(667) 220-6048
drdom@wholebodyhealthcare.com
(678) 697-4771
IGNITECHIRO22@gmail.com
(863) 220-0099
cjcvet@icloud.com
(828) 859-5004
drjpicone@gmail.com
(337) 240-6433
drsavoie@rysechiro.com
(610) 692-7560
lauren.jones@ahccvet.com
(724) 317-5626
info@crahvets.com
(904) 310-3950
holisticwellnessfb@gmail.com
(804) 551-0519
info@scottsadditionanimalhospital.com
(330) 549-1111
info@angelsforanimals.org
(252) 257-0737
wac2570737@gmail.com
(919) 847-3959
greaterchiro@gmail.com
(217) 398-4871
cheryl@gumdoc.net
(408) 805-4325
info@mindflowchiropractice.com
(484) 281-8080
hanoverviewde@gmail.com
(941) 756-5544
josie.tyree@nva.com
(636) 386-5900
docboen@gmail.com
(978) 821-9014
drshellyking@gmail.com
(770) 505-7387
newgah@hotmail.com
(559) 470-4864
jeland@spoc-ortho.com
(804) 393-3217
Sallen@summuslaser.com
(262) 989-3880
dravipatelchiropractic@gmail.com
(403) 605-8799
kjconn2004@yahoo.com
(571) 442-8161
drjohn@asi-nova.com
(503) 256-3180
dr.billmoreau@dconline.org
(310) 243-6599
hello@economicoah.com
(410) 569-5969
reedneubaum@gmail.com
(603) 953-3602
joel@durhamdc.com
(541) 233-8924
dmflitner@msn.com
(757) 473-9900
proadjusterchiorvb@gmail.com
(803) 995-6737
info@lifeexpressinshwc.com
(229) 883-0042
drwren@drdaviswren.com
(317) 690-9323
Drdave@superdopechiro.com
(615) 973-7767
chirodocben@aol.com
(843) 446-3008
rshamah@summuslaser.com
(317) 343-9040
drsalata@miccindy.com
(860) 836-1779
drcutting@cuttingedgechiro.com
(417) 742-2617
wfcadrkim@gmail.com
(773) 573-2164
info@greystonegenmed.com
(919) 484-1400
drdubois@swisschiropractic.com
(573) 772-5451
office@dayonechiro.com
(864) 590-9310
drkd@balancedlifewell.com
(910) 763-3611
drreesedc@gmail.com
(720) 951-2884
helmsryan1125@gmail.com
(636) 925-1919
ericleitman@gmail.com
(818) 570-1540
drchiro1@gmail.com
(843) 225-1236
axischirocare@gmail.com
(704) 791-2366
drericlkn@gmail.com
(804) 241-6450
craigmb2017@gmail.com
(757) 427-0355
dramanda@bodylogic.com
(931) 451-8125
freedomspinecare@gmail.com
(919) 263-9894
drjenadc@yahoo.com
(615) 595-7749
Cperry@summuslaser.com
(843) 981-4500
thebodyfixchiro@gmail.com
(314) 750-7361
Tonjamattias@outlook.com
(708) 372-6355
drmcparland@ihsop.com
(678) 513-0095
nmcs.info@gmail.com
(864) 881-4221
drchristopherdoyle2@gmail.com
(570) 994-6437
dmate@getback2health.com
(865) 984-2001
alcoachiro@gmail.com
(224) 242-4338
clark6782@gmail.com
(330) 674-0444
staushcass@gmail.com
(913) 905-9424
drchris@apexchirokc.com
(757) 253-1900
wgghome@gmail.com
(573) 701-0770
isaac@armstrongspinesport.com
(307) 885-9053
drhuntsmandc@gmail.com
(619) 942-5550
chirojoesnyder@gmail.com
(978) 621-9863
ascdrc@gmail.com
(903) 887-1417
drword@wordchiro.com
(416) 751-2504
drandvsomogyi@gmail.com
(615) 595-7759
Jking@summuslaser.com
(919) 847-3959
Gadsae1995@yahoo.com
(336) 568-8822
Shaneacobb@gmail.com
(864) 366-7777
2811enterprises@gmail.com
(574) 339-1793
drklauer@tmjsleepindiana.com
(417) 881-4994
asutton@kare-health.com
(512) 330-9403
Shane@authenticsmiles.com
(704) 657-1337
myreshape@gmail.com
(636) 639-8994
wentzvillecac@gmail.com
(262) 251-7711
drdegrungh@yahoo.com
(618) 589-9400
erictoenniesdc@gmail.com
(561) 843-6328
atc5@comcast.net
(281) 467-5184
drmurudeen@bayoucityfa.com
(803) 760-7862
ataylor24887@gmail.com
(619) 981-7071
DRHERFINDAHL@GMAIL.COM
(913) 268-6070
legacychiropractic@gmail.com
(713) 336-3593
sbradshaw@lschropractic.com
(770) 614-7242
absolutespine.health@gmail.com
(704) 800-4540
dr@elementchironc.com
(912) 988-1019
office@bomberychiropractic.com
(855) 355-3278
harry@hkcreativeinvestments.com
(229) 886-4692
drlarsen@bellsouth.net
(814) 944-8483
mickeybumbargerdc@gmail.com
(864) 800-1817
contact@highlandschirogvl.com
(708) 588-8270
b2boyd@gmail.com
(678) 765-6230
pyi@doctor.com
(404) 264-9553
info.drcarlisledc@gmail.com
(407) 857-6166
drjeff@orangewellness.com
(515) 227-7491
drjosh@activehealthchiro.com
(803) 788-8831
office@columbiafamilychiro.com
(636) 778-9997
michelle@stlopc.com
(919) 8675797
ortman.matthew@gmail.com
(901) 763-8583
ortmanchiropractic@gmail.com
(636) 706-6171
drhendrix@trossspine.com
(919) 895-6339
dr.p@backtobasicsmedical.com
(678) 902-7900
sparkproandrehab@gmail.com
(502) 290-7876
info@lasercenterlousville.com
(334) 707-8550
gregoryf@auburn.edu
+971529210062
consultant@highskyco.com
(215) 499-3797
dr@backdrphilly.com
(212) 336-3827
avi@manhattanmedicalassociates.com
(720) 840-9024
keith.dugger@rockies.com
(615) 595-7749
rshamah@summuslaser.com
(541) 892-8905
essexvetservices@outlook.com
806.236.2206
randy@painreliefondemand.com
(615) 343-7763
justin.wenzel@vumc.org
(404) 985-6209
info@evolveatl.net
(770) 977-8556
schad.john@hotmail.com
(843) 892-5671
Drbradgorski@gmail.com
(314) 524-2580
dr.robyn@getwellfc.com
(801) 360-7388
gunnerson88@hotmail.com
(678) 513-0095
kyle.fpgel@gmail.com
(314) 432-2329
michaelthompsondc@gmail.com
(919) 660-9000
aurelio.alonso@duke.edu
(901) 380-0734
tmjcare@gmail.com
(203) 941-0577
dr.piacentedc@gmail.com
(314) 721-2140
kim@drmichaelschoenwalder.com
(215) 632-3074
drh@backrphilly.com
(404) 870-0191
Chris@midtownlifestudio.com
(203) 793-7147
dr.stephanie10@gmail.com
(804) 393-3217
dexallen@yahoo.com
(314) 442-4452
dsrmd21@gmail.com
(361) 425-5489
shs.my.office@gmail.com
(901) 210-7206
drg38654@gmail.com
(205) 874-9699
drhartsfield@tmjandsleepsolutions.com
(615) 475-3405
dremilyburgess@icloud.com
(704) 752-7227
office@carolinasvet.com
(318) 640-7153
haasanimalhospital@aol.com
(727) 619-4800
ellen@beconer.vet.com
(480) 659-2277
madison@nexusrehabspine.com
(931) 591-3740
sourcechiro@gmail.com
(205) 991-5446
jvargas@doubleoakmountainvet.com
(425-243-2492
Hello@felixandfido.com
531-500-1944
elevatedhealth@gmail.com
931-591-3740
sourcechiro@gmail.com
843-446-3008
rshamah@summuslaser.com
323-852-8450
drtsaicm@gmail.com
901-861-0716
drjeffcarr@hotmail.com
828-382-8005
drking@seintegrativehealth.com
574-968-5166
drklauer@tmjsleepindiana.com
972-355-0083
drstann@epichealthfm.com
952-985-5444
betzinaryan@yahoo.com
(806) 236-2206
randy@painreliefondemand.com
305-699-6751
drfox@foxpt.com
314-486-3458
matt@mattbrowncoach.com
843-8798224
admin@charlestonhealth.org
803-772-3300
mattboyeson@gmail.com
615-989-0660
jason.gant@inspiredpt.org
575-519-1176
drsmith@smithwellnessic.com
(843) 882-5012
patrickjones@portsidvet.com
404-2370317
zvrono@brookhavenanimalhsoptial.com
(252) 320-0859
welcome.waggin@yahoo.com
323-462-0660
rsf.lauren@yahoo.com
(804) 561-2244
dreddadvm@aol.com
(425) 243-2492
Hello@felixandfido.com
(804) 897-8522
ewervet1@msn.com
330-823-7211
1472aah@gmail.com
671-649-4871
dr.dccns@gmail.com
(610) 367-4744
dr.alivemini@gilbertsvillvet.com
(843) 554-4361
tkbenton99@yahoo.com
770-537-6705
pricecreek@yahoo.com
(937) 806-3410
contact.us@moorevethospital.com
(479) 202-4886
lorrie.wolf@allpetsnwa.com
(318) 562-5878
bakerveterinaryservices520@gmail.com
615-794-5685
beauchampanimalhospital@comcast.net
253-838-5531
kidhester@comcast.net
336-227-9979
sbeeking@gmail.com
228-467-3910
dseaton621@gmail.com
(641) 895-6114
parksideanimalhospital@gmail.com
(763) 755-2570
docepping@gmail.com
(315) 668-7387
info@highlandanimalhospitalcny.com
406-788-4096
sky@3riversbs.net
(615) 595-7749
rshammah@summuslaser.com
201-724-8081
drkapoor@hobokensmilespecialists.com
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