DEVICE: Platinum (B679KP40)
Device Identifier (DI) Information
Platinum
KP4
Not in Commercial Distribution
KP4
SUMMUS MEDICAL LASER, LLC
KP4
Not in Commercial Distribution
KP4
SUMMUS MEDICAL LASER, LLC
Therapeutic medical laser device 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 are in the form of non ionizing radiation in which the invisible light wave doses and visible light wave aiming beam 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.
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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Handling Environment Atmospheric Pressure: between 86 and 106 KiloPascal |
| Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature: between 10 and 30 Degrees Celsius |
| Storage Environment Temperature: between 0 and 35 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
1aa98db8-531a-4221-80fc-2d60835c8e7d
January 10, 2025
14
August 16, 2018
January 10, 2025
14
August 16, 2018
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
732-840-8989
drjaymermelstein@gmail.com 678-333-3751
drkristina@elitetotalwellness.com 310-268-8008
muscledr@earthlink.net 813-870-9000
toni@skinsavvyrx.com 253-528-0172
wadrhur@gmail.com 775-746-2206
admin@backinmotion.net 716-523-8931
chris.fischetti@bills.nfl.net 916-771-3999
drboley@hotmail.com 313-462-8226
piet.vanzant@hockeytown.com 931-967-4199
rudderchiropractic@att.net 601-856-6950
jonesdr@bellsouth.net 703-753-8080
drhaupt@gateway-chiropractic.com 814-838-8877
vwchiro@yahoo.com 703-851-1259
potochiro6@aol.com 714-267-2220
drstevendunbar@yahoo.com 603-785-5615
saibhung@peterboroughchiropractic.com 970-247-8415
luke.angel@centrua.org 302-628-8706
backdr98@aol.com 617-327-7618
jtrahan18@comcast.net 417-881-4994
asutton@kare-health.com 540-943-1434
knizner1@lumos.net 909-797-1705
rjarrett@jarretchiro.com 857-366-0794
bpearson@redsox.com 202-974-6621
csimonreleasept@gmail.com 727-492-0700
rreed@gmail.com 425-558-9998
tkhach3@gmail.com 714-541-5433
drbrian@cox.nwet 985-845-9000
ckelloggspecialtyphysicians@gmail.com 952-985-5444
betzinaryan@yahoo.com 651-646-2050
perrychiro@hotmail.com 571-442-8161
dr_cpjohn@yahoo.com 808-280-9499
adg3@me.com 515-955-7724
drbenacree@gmail.com 863-680-1064
drcheatwoodtampabay@gmial.com 602-603-5444
dave.iszler@gmail.com 503-648-4357
richardson.johnc@gmail.com 916-366-5500
drfugitt@pacbell.net 217-942-6272
drjhamel@gmail.com 815-254-9697
doconnordc@yahoo.com 510-446-2225
elliot.sclamberg@gmail.com 773-972-6566
naprapath@gmail.com 985-845-9000
ckellogg@specialtyphysicians.net 303-353-8294
thirty3chiropractic@yahoo.com 770-428-4909
mariettachiropractic@gmail.com 801-664-4691
nathandmartin@yahoo.com 715-623-2123
rob@antigochiro.com 917-664-0425
wallycourt@aol.com 815-776-7610
healingwatersgalena@gmail.com 941-752-7246
broogster@msn.com 706-782-2512
rhvail@windstream.net 541-388-2429
drterrydoi@gmail.com 570-489-9300
dc4kidz@aol.com 614-292-5134
obrien.20@osu.edu 636-227-2100
laney.nelson@logan.edu 925-932-3289
chiropractic1@sbcglobal.net 516-679-1207
lobergh@advance-pt.com 516-781-4811
peterdc@optonline.net 414-272-7250
chirobernie@aol.com 509-783-7145
akridgechiropractic@yahoo.com 615-459-6700
jrudd@aol.com 949-783-8454
dr.michaelsen@me.com 812-363-5634
drbjwallpe@gmail.com 573-808-2413
mjtellor1@gmail.com 303-598-1999
jdenning@denversports.com 707-889-0995
drlaura@pulsewave.com 256-739-0140
lisaweeks_01@bellsouth.net 210-614-7594
david.hrncir@earthlink.net 312-543-4492
kaufyk@aol.com 715-298-3834
ruppel1@yahoo.com 541-494-1111
btquave@yahoo.com 616-698-0046
tjbbackdoc@aol.com 616-696-0046
bcc.ryanburkhart@gmail.com 972-930-9566
shuch1@yahoo.com 209-951-8650
jdirwindc@sbcglobal.net 607-321-7674
chirosportandspine@gmail.com 248-390-0534
drhaddad@rochesteradvanceddentistry.com 760-413-2254
tutconsultant@gmail.com 662-846-7730
doc38732@yahoo.com 309-862-2225
heartland1713@aol.com 408-999-5866
rtufts@sjsharks.com 631-470-9670
balance198@aol.com 469-237-4637
drlopezchiro@gmail.com 228-575-8660
drsonya1@msn.com 723-752-7464
drdadair@yahoo.com 303-830-2064
mary@nbr-services.com 480-751-6199
drlaurietrapp@hotmail.com 562-324-5976
hyundonglee@gmail.com 541-494-1111
jmoses@quaveclinic.com 603-679-8100
bodywise.llc@gmail.com 563-343-2275
drpatkingpremierwellness@gmail.com 570-578-0953
drrowena@dejesusfamilychiro.com 931-647-1199
lnebben@gmail.com 718-760-2800
acupain9@gmail.com 212-535-0229
institutebeaute@gmail.com 901-794-0876
info@smithchiropracticcordova.com 541-770-1330
drblenkush@aol.com 540-943-1334
knizner1@lumos.net 985-778-0880
onicchiro@live.com 718-496-0364
4321allsystemsgo@gmail.com 334-737-6840
info@genesishealthauburn.com 410-484-8610
rob@advantagepo.com 248-752-7456
jkkrad@aol.com 256-737-9500
caryb328@aol.com 949-600-8990
drdavis.kolvita@yahoo.com 847-910-2567
drwalkerstemcell@gmail.com 919-895-6339
dr.p@backtobasicsmedical.com 412-655-8171
info@lfchiro.com 509-737-9355
drryan@newedgewellness.com 804-625-4064
drvaughan@vatotalsleep.com 516-806-2200
hicksvillehappyfeet@gmail.com 334-308-2225
alignchiro@troycable.net 716-829-3479
prarany@buffalo.edu 386-454-4055
jpachiro@gmail.com 859-278-8000
docleo@protonmail.com 609-661-0101
dr.lerman@yahoo.com 570-578-4900
indigochiro@gmail.com 734-274-5107
drl@drlazar.com 917-732-3616
ckang@kangchiropractic.com 937-479-7930
linzie.crute@gmail.com 717-299-9600
shayne_bushong@yahoo.com 214-385-4861
donbufordmd@gmail.com 614-553-2129
dmartin@henryscheinvet.com 850-785-4344
kellumethan6@gmail.com 305-444-7870
gablespodiatry@gmail.com 909-783-4950
g.t.c.2004@sbcglobal.net 561-775-2092
drthaw@pgachiro.com 808-557-3540
lokenanisouza@gmail.com 716-668-2225
buffalochiroctr@aol.com 866-805-8555
tim.ridner@bears.nfl.net 352-435-7849
doctoez@yahoo.com 808-270-0436
walkerchiromaui@gmail.com 407-723-0090
robert.abraham@cryonext.tech 205-663-5444
drneckbone@gmail.com 618-524-4445
jeffe@linwoodmotors.com 201-875-5757
info@ignitetherapy.com 907-456-4234
advancedchiropracticfairbanks@gmail.com 985-778-0880
tonicchiro@live.com 415-399-9909
mokshalifecenter@gmail.com 715-881-1411
doccessna@gmail.com 954-755-4994
lewertron@gmail.com 703-738-4371
ashanbhag@treatingpain.com 202-974-6621
csimon@releasept.com 256-837-8111
drbryant@hiwaay.net 425-641-8052
brock.barnick@gmail.com 713-522-9814
djmitchell@naturalhealthhouston.com 337-424-9318
doctorjmc99@yahoo.com (740) 387-7246
akatabay@hotmail.com (717) 299-9600
shayne_bushong@yahoo.com (919) 367-2828
drcreech@creechchiropractic.com (336) 548-2225
khlineberry@yahoo.com (410) 484-8610
rob@advantagepo.com (248) 752-7456
jkkrad@aol.com (256) 737-9500
caryb328@aol.com (949) 600-8990
drdavis.kolvita@yahoo.com (847) 910-2567
ddrwalkerstemcell@gmail.com (808) 270-0436
walkerchiromaui@gmail.com 952-746-4404
info@lifeforcefamilychiropractic.org (509) 737-9355
drchris@newedgewellness.com (202) 974-6621
csimon@releasept.com (804) 625-4064
drvaughan@vatotalsleep.com (480) 681-7979
drketcher@gorenewhealth.com (859) 469-1409
kicourt@aol.com (480) 797-9764
Pharrington@summuslaser.com
drjaymermelstein@gmail.com 678-333-3751
drkristina@elitetotalwellness.com 310-268-8008
muscledr@earthlink.net 813-870-9000
toni@skinsavvyrx.com 253-528-0172
wadrhur@gmail.com 775-746-2206
admin@backinmotion.net 716-523-8931
chris.fischetti@bills.nfl.net 916-771-3999
drboley@hotmail.com 313-462-8226
piet.vanzant@hockeytown.com 931-967-4199
rudderchiropractic@att.net 601-856-6950
jonesdr@bellsouth.net 703-753-8080
drhaupt@gateway-chiropractic.com 814-838-8877
vwchiro@yahoo.com 703-851-1259
potochiro6@aol.com 714-267-2220
drstevendunbar@yahoo.com 603-785-5615
saibhung@peterboroughchiropractic.com 970-247-8415
luke.angel@centrua.org 302-628-8706
backdr98@aol.com 617-327-7618
jtrahan18@comcast.net 417-881-4994
asutton@kare-health.com 540-943-1434
knizner1@lumos.net 909-797-1705
rjarrett@jarretchiro.com 857-366-0794
bpearson@redsox.com 202-974-6621
csimonreleasept@gmail.com 727-492-0700
rreed@gmail.com 425-558-9998
tkhach3@gmail.com 714-541-5433
drbrian@cox.nwet 985-845-9000
ckelloggspecialtyphysicians@gmail.com 952-985-5444
betzinaryan@yahoo.com 651-646-2050
perrychiro@hotmail.com 571-442-8161
dr_cpjohn@yahoo.com 808-280-9499
adg3@me.com 515-955-7724
drbenacree@gmail.com 863-680-1064
drcheatwoodtampabay@gmial.com 602-603-5444
dave.iszler@gmail.com 503-648-4357
richardson.johnc@gmail.com 916-366-5500
drfugitt@pacbell.net 217-942-6272
drjhamel@gmail.com 815-254-9697
doconnordc@yahoo.com 510-446-2225
elliot.sclamberg@gmail.com 773-972-6566
naprapath@gmail.com 985-845-9000
ckellogg@specialtyphysicians.net 303-353-8294
thirty3chiropractic@yahoo.com 770-428-4909
mariettachiropractic@gmail.com 801-664-4691
nathandmartin@yahoo.com 715-623-2123
rob@antigochiro.com 917-664-0425
wallycourt@aol.com 815-776-7610
healingwatersgalena@gmail.com 941-752-7246
broogster@msn.com 706-782-2512
rhvail@windstream.net 541-388-2429
drterrydoi@gmail.com 570-489-9300
dc4kidz@aol.com 614-292-5134
obrien.20@osu.edu 636-227-2100
laney.nelson@logan.edu 925-932-3289
chiropractic1@sbcglobal.net 516-679-1207
lobergh@advance-pt.com 516-781-4811
peterdc@optonline.net 414-272-7250
chirobernie@aol.com 509-783-7145
akridgechiropractic@yahoo.com 615-459-6700
jrudd@aol.com 949-783-8454
dr.michaelsen@me.com 812-363-5634
drbjwallpe@gmail.com 573-808-2413
mjtellor1@gmail.com 303-598-1999
jdenning@denversports.com 707-889-0995
drlaura@pulsewave.com 256-739-0140
lisaweeks_01@bellsouth.net 210-614-7594
david.hrncir@earthlink.net 312-543-4492
kaufyk@aol.com 715-298-3834
ruppel1@yahoo.com 541-494-1111
btquave@yahoo.com 616-698-0046
tjbbackdoc@aol.com 616-696-0046
bcc.ryanburkhart@gmail.com 972-930-9566
shuch1@yahoo.com 209-951-8650
jdirwindc@sbcglobal.net 607-321-7674
chirosportandspine@gmail.com 248-390-0534
drhaddad@rochesteradvanceddentistry.com 760-413-2254
tutconsultant@gmail.com 662-846-7730
doc38732@yahoo.com 309-862-2225
heartland1713@aol.com 408-999-5866
rtufts@sjsharks.com 631-470-9670
balance198@aol.com 469-237-4637
drlopezchiro@gmail.com 228-575-8660
drsonya1@msn.com 723-752-7464
drdadair@yahoo.com 303-830-2064
mary@nbr-services.com 480-751-6199
drlaurietrapp@hotmail.com 562-324-5976
hyundonglee@gmail.com 541-494-1111
jmoses@quaveclinic.com 603-679-8100
bodywise.llc@gmail.com 563-343-2275
drpatkingpremierwellness@gmail.com 570-578-0953
drrowena@dejesusfamilychiro.com 931-647-1199
lnebben@gmail.com 718-760-2800
acupain9@gmail.com 212-535-0229
institutebeaute@gmail.com 901-794-0876
info@smithchiropracticcordova.com 541-770-1330
drblenkush@aol.com 540-943-1334
knizner1@lumos.net 985-778-0880
onicchiro@live.com 718-496-0364
4321allsystemsgo@gmail.com 334-737-6840
info@genesishealthauburn.com 410-484-8610
rob@advantagepo.com 248-752-7456
jkkrad@aol.com 256-737-9500
caryb328@aol.com 949-600-8990
drdavis.kolvita@yahoo.com 847-910-2567
drwalkerstemcell@gmail.com 919-895-6339
dr.p@backtobasicsmedical.com 412-655-8171
info@lfchiro.com 509-737-9355
drryan@newedgewellness.com 804-625-4064
drvaughan@vatotalsleep.com 516-806-2200
hicksvillehappyfeet@gmail.com 334-308-2225
alignchiro@troycable.net 716-829-3479
prarany@buffalo.edu 386-454-4055
jpachiro@gmail.com 859-278-8000
docleo@protonmail.com 609-661-0101
dr.lerman@yahoo.com 570-578-4900
indigochiro@gmail.com 734-274-5107
drl@drlazar.com 917-732-3616
ckang@kangchiropractic.com 937-479-7930
linzie.crute@gmail.com 717-299-9600
shayne_bushong@yahoo.com 214-385-4861
donbufordmd@gmail.com 614-553-2129
dmartin@henryscheinvet.com 850-785-4344
kellumethan6@gmail.com 305-444-7870
gablespodiatry@gmail.com 909-783-4950
g.t.c.2004@sbcglobal.net 561-775-2092
drthaw@pgachiro.com 808-557-3540
lokenanisouza@gmail.com 716-668-2225
buffalochiroctr@aol.com 866-805-8555
tim.ridner@bears.nfl.net 352-435-7849
doctoez@yahoo.com 808-270-0436
walkerchiromaui@gmail.com 407-723-0090
robert.abraham@cryonext.tech 205-663-5444
drneckbone@gmail.com 618-524-4445
jeffe@linwoodmotors.com 201-875-5757
info@ignitetherapy.com 907-456-4234
advancedchiropracticfairbanks@gmail.com 985-778-0880
tonicchiro@live.com 415-399-9909
mokshalifecenter@gmail.com 715-881-1411
doccessna@gmail.com 954-755-4994
lewertron@gmail.com 703-738-4371
ashanbhag@treatingpain.com 202-974-6621
csimon@releasept.com 256-837-8111
drbryant@hiwaay.net 425-641-8052
brock.barnick@gmail.com 713-522-9814
djmitchell@naturalhealthhouston.com 337-424-9318
doctorjmc99@yahoo.com (740) 387-7246
akatabay@hotmail.com (717) 299-9600
shayne_bushong@yahoo.com (919) 367-2828
drcreech@creechchiropractic.com (336) 548-2225
khlineberry@yahoo.com (410) 484-8610
rob@advantagepo.com (248) 752-7456
jkkrad@aol.com (256) 737-9500
caryb328@aol.com (949) 600-8990
drdavis.kolvita@yahoo.com (847) 910-2567
ddrwalkerstemcell@gmail.com (808) 270-0436
walkerchiromaui@gmail.com 952-746-4404
info@lifeforcefamilychiropractic.org (509) 737-9355
drchris@newedgewellness.com (202) 974-6621
csimon@releasept.com (804) 625-4064
drvaughan@vatotalsleep.com (480) 681-7979
drketcher@gorenewhealth.com (859) 469-1409
kicourt@aol.com (480) 797-9764
Pharrington@summuslaser.com