Consulting Wallah › Device Explorer › Other devices › Musculoskeletal/physical therapy laser, home-use
Device Explorer · FDA GUDID · GMDN 60410

Musculoskeletal/physical therapy laser, home-use

An electrically-powered diode laser intended to provide noninvasive laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, rheumatism, disorders of th

US‑registered devices91in commercial distribution
Companies15labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription25%Rx‑only share
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Share of device records

Powermedic Aps5358%
Microlight Corporation Of America910%
Lumiton Medical Products Llc55%
Stellar Lasers Llc55%
Luminance Medical Ventures Incorporated44%
528 Innovations Llc44%
Pivotal Health Solutions, Inc.22%
Lzr7, Inc.22%

Top labelers

CompanyDevicesShare
Powermedic Aps5358%
Microlight Corporation Of America910%
Lumiton Medical Products Llc55%
Stellar Lasers Llc55%
Luminance Medical Ventures Incorporated44%
528 Innovations Llc44%
Pivotal Health Solutions, Inc.22%
Lzr7, Inc.22%
Curabeam Medical Technology Co.,Ltd.11%
Rhein Laser Technologies Co.,Ltd.11%
Wuhan Guangdun Technology Co.,Ltd.11%
Zmi Electronics Ltd.11%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CuraBeamSmart Laser Therapy SystemLASPOTPowerLaser Pro1500 WhitePowerLaser Pro1500 RedPowerLaser Pro1500 BlackPowerLaser Pro1200 RedPowerLaser Pro1200 BlackPowerLaser Pro500 WhitePowerLaser Pro500 RedPowerLaser Pro500 BlackPowerLaser Pro1500 VET WhitePowerLaser Pro1500 VET RedPowerLaser Pro1500 VET BlackPowerLaser Pro500 VET WhitePowerLaser Pro500 VET Red

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
ILYLamp, Infrared, Therapeutic Heating116
NHNPowered Light Based Non-Laser Non-Thermal Instrument With No9
NHNPowered Light Based Laser Non-Thermal Instrument With Non-He1
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter1
NZYLight, Lymphedema Reduction, Low Energy1

GMDN & GCC registration

  • GMDN code 60410 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 25% · OTC 62%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many musculoskeletal/physical therapy laser, home-use products are registered in the US?

91 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Musculoskeletal/physical therapy laser, home-use", from 15 companies. The largest labeler is Powermedic Aps with 58% of records.

Which FDA product codes apply?

ILY (Lamp, Infrared, Therapeutic Heating), NHN (Powered Light Based Non-Laser Non-Thermal Instrument With No), NHN (Powered Light Based Laser Non-Thermal Instrument With Non-He), NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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