Consulting Wallah › Device Explorer › Other devices › Red-light phototherapy unit, professional
Device Explorer · FDA GUDID · GMDN 45688

Red-light phototherapy unit, professional

An electrically-powered device designed to emit red light for phototherapy primarily to accelerate healing of cutaneous/mucosal wounds, treat mild skin disorders (e.g., mild acne), intraoral or nasal conditions, and/or treat musculoskeletal symptoms (e.g., pai

US‑registered devices121in commercial distribution
Companies15labelers on GUDID
Single‑use3%of device records
Sterile1%labelled sterile
Prescription15%Rx‑only share
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Share of device records

Thor Photomedicine Limited7058%
Meditech International Inc2117%
Tanses Technologies Inc54%
Lutronic Corporation54%
Mureva Phototherapy Inc.43%
Biolux Technology Gmbh43%
Applied Biophotonics Limited22%
Btl Industries Limited22%

Top labelers

CompanyDevicesShare
Thor Photomedicine Limited7058%
Meditech International Inc2117%
Tanses Technologies Inc54%
Lutronic Corporation54%
Mureva Phototherapy Inc.43%
Biolux Technology Gmbh43%
Applied Biophotonics Limited22%
Btl Industries Limited22%
Zhangzhou Win Share Co.,Ltd.22%
Lasxbot (Shenzhen) Robot Co., Ltd11%
Shenzhen Kaiyan Medical Equipment Co,. Ltd11%
Biolux Research Limited11%

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

Brand names on the register (sample)

SummusKINEONTrigger Point HandpieceSmall LED ClusterMedium LED ClusterLarge LED ClusterGiant Laser ClusterLaser ClusterRed LaserRed Acutip LaserTrigger Point LaserNIR Acutip Laser104 LED Cluster issue 319 LED Cluster issue 369 LED Cluster issue 3660nm 75mW Red Light Guide Laser

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 Heating109
PLHOrthodontic Led Accessory5
SGQIntraoral Phototherapy Device4
NHNPowered Light Based Laser Non-Thermal Instrument With Non-He3
NHNPowered Light Based Non-Laser Non-Thermal Instrument With No2
NACDressing, Wound, Hydrophilic2

GMDN & GCC registration

  • GMDN code 45688 · non‑implantable
  • Single‑use 3% · sterile 1% · Rx‑only 15% · OTC 3%
  • 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 red-light phototherapy unit, professional products are registered in the US?

121 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Red-light phototherapy unit, professional", from 15 companies. The largest labeler is Thor Photomedicine Limited with 58% of records.

Which FDA product codes apply?

ILY (Lamp, Infrared, Therapeutic Heating), PLH (Orthodontic Led Accessory), SGQ (Intraoral Phototherapy Device), NHN (Powered Light Based Laser Non-Thermal Instrument With Non-He)

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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