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Device Explorer · FDA GUDID · GMDN 58786

Dermatological diode laser system

A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam designed to perform dermatological procedures such as body hair removal (e.g., armpit, leg/arm, back, chest, bikini lin

US‑registered devices159in commercial distribution
Companies52labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription58%Rx‑only share
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Share of device records

Tria Laser Inc117%
Lumenis Be Ltd106%
Beijing Adss Development Co., Ltd.106%
Lutronic Corporation106%
Wingderm Electro-Optics Ltd.85%
Shandong Huamei Technology Co.,Ltd.74%
Shanghai Apolo Medical Technology Co.,Ltd74%
Luvo Medical Technologies Inc74%

Top labelers

CompanyDevicesShare
Tria Laser Inc117%
Lumenis Be Ltd106%
Beijing Adss Development Co., Ltd.106%
Lutronic Corporation106%
Wingderm Electro-Optics Ltd.85%
Shandong Huamei Technology Co.,Ltd.74%
Shanghai Apolo Medical Technology Co.,Ltd74%
Luvo Medical Technologies Inc74%
Alma Lasers Ltd.74%
Ilooda.Co.,Ltd74%
Asclepion Laser Technologies Gmbh53%
Rhein Laser Technologies Co.,Ltd.43%

Company = labeler of record on GUDID. 52 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LightSheer DesireLightSheer® Quattro™ LightLightSheer® XC 1060 HandpieceLightSheer® HS 1060 HandpieceLightSheer® ET 1060 HandpieceLightSheer® XC 805 HandpieceLightSheer® ET 805 HandpieceLightSheer® HS 805 HandpieceLightSheer® Quattro™PURE Laser, SystemDioBreezeMagma SparkDiolazeEpileve Applicator Service Pack UDI LabelDiode Laser Hair Removal MachineZHEONE

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

FDA product codes

CodeNameDevices
GEXPowered Laser Surgical Instrument172
ONGPowered Laser Surgical Instrument With Microbeam\Fractional 13
ILYLamp, Infrared, Therapeutic Heating7
ONFPowered Light Based Non-Laser Surgical Instrument With Therm6
ONEPowered Light Based Non-Laser Surgical Instrument5
OHTLight Based Over-The-Counter Hair Removal4

GMDN & GCC registration

  • GMDN code 58786 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 58% · OTC 9%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Depth (Inch) · 1Width (Inch) · 1Height (Inch) · 1

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

How many dermatological diode laser system products are registered in the US?

159 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dermatological diode laser system", from 52 companies. The largest labeler is Tria Laser Inc with 7% of records.

Which FDA product codes apply?

GEX (Powered Laser Surgical Instrument), ONG (Powered Laser Surgical Instrument With Microbeam\Fractional ), ILY (Lamp, Infrared, Therapeutic Heating), ONF (Powered Light Based Non-Laser Surgical Instrument With Therm)

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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