DEVICE: Platinum (B679SLH10)

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Device Record History
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Device Identifier (DI) Information
Platinum
SLH1
In Commercial Distribution
SLH1
SUMMUS MEDICAL LASER, LLC
B679SLH10
HIBCC

1
621560338 *Terms of Use
Light weight (~2 Kg.) and portable therapeutic medical laser device (measuring ~225 mm x 150 mm x 150 mm) 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.
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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
Storage Environment Temperature: between 0 and 35 Degrees Celsius
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 86 and 106 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
695c099e-bb40-460c-8d72-4b5684c2ac60
July 23, 2024
31
August 14, 2019
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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

[?]
+660909860397
siriphen.s@getzhealthcare.com
(732) 920-8188
jimhigginsdc@comcast.net
+3864198897
info@fizian.si
(704) 881-1587
susannnegordon@mac.com
(414) 323-7755
contact@healthypawsclinics.com
(804) 512-9944
graze@dragonflyfarms.com
(770) 447-3927
info@kmvs.org
(787) 798-3001
uccaribe.eduvilmarie.soto@uccaribe.edu
+886287513333
mjhong@yuanyu.tw
(252) 521-4379
bpcivatte@yahoo.com
(936) 442-4311
angela.haltom@mctx.org
(703) 939-5129
jpodell@nymets.com
(501) 837-7106
bhvets@gmail.com
(352) 327-4262
team@warriorwellness.co
(360) 319-2558
bavarianchiropracticclinic@gmail.com
+886287513333
ypcheng@yuanyu.tw
(919) 895-6339
dr.p@backtobasicsmedical.com
(615) 595-7749
Delphine.verhelst@medini.be
(678) 208-9000
northforsythvet@gmail.com
(424) 384-1808
cstone@annenbergpetspace.org
(561) 420-3273
Thonas@libertotherapy.com
(901) 273-2273
jsullivandvm@aol.com
(541) 689-7881
mick@thearkveterinaryclinic.com
519-587-2980
chantal@hobbitstee.com
(516) 679-1207
lobergh@advance-pt.com
(315) 853-3551
clintonpetvet@gmail.com
(480) 812-1800
ralf@robertsonfamilychiro.com
(205) 370-8664
trussvilleanimal@aol.com
(818) 424-5021
lmwendtdvm@gmail.com
(724) 655-3090
houstonmobilevetsurgery@gmail.com
(972) 801-7984
drhartai@yahoo.com
(519) 587-2980
chantal@hobbitstee.com
(843) 225-4080
alexcooker@gmail.com
(561) 900-2680
glegerman@delrayanimal.com
615-595-7749
s.nakamura@asuka-med.com
(972) 690-6900
Scott@bpah.net
(705) 527-6867
Share@pureequinetherapy.com
(860) 677-0309
jfchace@comcast.net
(989) 354-2241
Drjill@sunriseveterinaryservices.com
(613) 267-6789
darryl@perthphysiotherapy.ca
(797) 408-6142
info@petsrelaxed.co.uk
(916) 406-5010
Ron.marasco@pattersonvet.com
(615) 595-7749
jun1nishimura@me.com
(703)-328-1183
CGBURKES@GMAIL.COM
(615) 595-7749
trungdyv@gmail.com
(615) 412-8793
aphillips@qwntmpt.com
(845) 592-4463
brookew@msn.com
615-595-7749
kmahe@centravet.fr
(609) 698-2141
h_schulman.bac@outlook.com
(615) 401-3511
info@davidturnerMD.com
(418) 540-4797
cliniquedejonquiere@outlook.com
(514) 978-1099
nbeaudoin@cliniquevitalis.com
(450) 669-8985
info@mtm.ca
(450) 424-5500
infor@clinique-podiatrique.com
(514) 578-7274
anthonycareccia@gmail.com
(309) 524-5696
contact@citylinevet.com
(450) 438-8863
c.charette@centre-podiatrique.ca
(517) 449-3407
drjill@sunriseveterinaryservices.com
(615) 595-7749
lucascubillos@ciccome.co
(615) 595-7749
info@livingsport.dk
(903) 887-1417
drword@wordchiro.com
(819) 355-4767
macliniquechiropratique@gmail.com
615-595-7749
nfo@elanus-medical.com
(843) 800-0413
drsamcurtis@yahoo.com
(317) 440-5940
drpinto@drchelseapinto.com
580-205-7966
info@mainstreetchiropractic.llc
250-477-8143
jason@backfit.ca
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