Platinum Series

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref SLH1

by Summus Medical Laser

Identity

Trade Name: Platinum Series EUDAMED
Platinum FDA UDI
Generic Name: Musculoskeletal/physical therapy laser, professional FDA UDI
Device Name: H1 EUDAMED
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. FDA UDI
Model / Reference: SLH1 EUDAMEDFDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: SLH1 FDA UDI
Primary DI / UDI-DI: +B679SLH10 EUDAMED
B679SLH10 FDA UDI
Basic UDI-DI: B-+B679SLH10 EUDAMED
FDA Product Code: ILY FDA UDI
EMDN Code: Z120615 THERAPEUTIC LASERS EUDAMED
GMDN Term: Musculoskeletal/physical therapy laser, professional FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 890.5500 FDA UDI
Market of Registration: Denmark EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Platinum Series by Summus Medical Laser — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-+B679SLH10	Class IIb	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIb	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Summus Medical Laser
EUDAMED SRN: US-MF-000015591
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (2)

EUDAMED ba206277-1d50-4b41-9c5a-044b02ad7b03 61 fields · synced Oct 7, 2026
FDA UDI 695c099e-bb40-460c-8d72-4b5684c2ac60 36 fields · synced May 30, 2026