Consulting Wallah › Device Explorer › Other devices › Dermatological laser beam guiding handpiece
Device Explorer · FDA GUDID · GMDN 45221

Dermatological laser beam guiding handpiece

A hand-held component of a dermatological laser system designed to conduct a therapeutic laser (e.g., solid state laser) from the laser generator to the treatment site for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesio

US‑registered devices173in commercial distribution
Companies18labelers on GUDID
Single‑use7%of device records
Sterile3%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Candela Corporation5129%
Solta Medical3520%
Quanta System Spa148%
Nira Innovations Incorporated116%
Vydence Medical116%
Viora Ltd95%
Cutera, Inc.95%
Lumenis Be Ltd74%

Top labelers

CompanyDevicesShare
Candela Corporation5129%
Solta Medical3520%
Quanta System Spa148%
Nira Innovations Incorporated116%
Vydence Medical116%
Viora Ltd95%
Cutera, Inc.95%
Lumenis Be Ltd74%
Venus Concept Ltd74%
Formatk Systems Ltd53%
Tria Laser Inc42%
Sanhe Laserconn Tech Co., Ltd.21%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

"M22 IPL ""AC"" Filter""M22 IPL ""VA"" Filter"Stellar M22™ ResurFX™ ModuleResurFX™ Precision TipResurFX™ SapphireCool™ TipResurFX™ HeadStellar M22™ ResurFX™ Module Upgrade KitV-Nd:YAG Spot 9.5 mmV-Nd:YAG Spot 5.5 mmV-Nd:YAG Spot 3.5 mmV-Nd:YAG Spot 2x4 mm²V-Nd:YAG Optics set FullV-Nd:YAG Optics set BasicV-Nd:YAG HP FullV-Nd:YAG HP BasicV-Nd:YAG HP

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 Instrument193
ONGPowered Laser Surgical Instrument With Microbeam\Fractional 26
OHSLight Based Over The Counter Wrinkle Reduction14
ONFPowered Light Based Non-Laser Surgical Instrument With Therm5
ILYLamp, Infrared, Therapeutic Heating3
PDZLasers For Temporary Increase Of Clear Nail In Patients With2

GMDN & GCC registration

  • GMDN code 45221 · non‑implantable
  • Single‑use 7% · sterile 3% · Rx‑only 88% · OTC 10%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Millimeter) · 2Length (Millimeter) · 2Height (Millimeter) · 2

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

How many dermatological laser beam guiding handpiece products are registered in the US?

173 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dermatological laser beam guiding handpiece", from 18 companies. The largest labeler is Candela Corporation with 29% of records.

Which FDA product codes apply?

GEX (Powered Laser Surgical Instrument), ONG (Powered Laser Surgical Instrument With Microbeam\Fractional ), OHS (Light Based Over The Counter Wrinkle Reduction), 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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