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Device Explorer · FDA GUDID · GMDN 47883

Dermatological solid-state laser system

A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod, or a fibre doped with a glass/crystal element (known as fibre laser), to emit a high-power laser beam intended to incis

US‑registered devices268in commercial distribution
Companies28labelers on GUDID
Single‑use12%of device records
Sterile0%labelled sterile
Prescription86%Rx‑only share
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Share of device records

Lutronic Corporation8231%
Candela Corporation6223%
Cynosure, Llc176%
Cynosure Lutronic Technology Corporation176%
Quanta System Spa114%
Acclaro Corporation104%
Cutera, Inc.104%
Laseroptek Co.,Ltd104%

Top labelers

CompanyDevicesShare
Lutronic Corporation8231%
Candela Corporation6223%
Cynosure, Llc176%
Cynosure Lutronic Technology Corporation176%
Quanta System Spa114%
Acclaro Corporation104%
Cutera, Inc.104%
Laseroptek Co.,Ltd104%
Bios Srl93%
Ddc Technologies, Inc.52%
Sharplight Technologies Ltd.41%
Wontech Co.,Ltd41%

Company = labeler of record on GUDID. 28 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Rapid QSRapid VanishRapid PeelOMNIMAX S4LeafPure-EchoATLAnchorfreeSOLAR Laser SystemsAvalancheLasePinPointe FootLaser FiberPinPointe FootLaserPolylaseEPY-50AL-40UltraClearAuraLux

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 Instrument332
GEXPowered laser surgical instrument16
PDZLasers For Temporary Increase Of Clear Nail In Patients With4
ONGPowered Laser Surgical Instrument With Microbeam\Fractional 3
PKTLaser for disruption of adipocyte cells for aesthetic use1
KKXDrape, surgical1

GMDN & GCC registration

  • GMDN code 47883 · non‑implantable
  • Single‑use 12% · sterile 0% · Rx‑only 86% · OTC 0%
  • 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 dermatological solid-state laser system products are registered in the US?

268 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dermatological solid-state laser system", from 28 companies. The largest labeler is Lutronic Corporation with 31% of records.

Which FDA product codes apply?

GEX (Powered Laser Surgical Instrument), GEX (Powered laser surgical instrument), PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With), ONG (Powered Laser Surgical Instrument With Microbeam\Fractional )

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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