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Device Explorer · FDA GUDID · GMDN 61473

Dermatological carbon dioxide laser system

A mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam, intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacin

US‑registered devices119in commercial distribution
Companies30labelers on GUDID
Single‑use5%of device records
Sterile2%labelled sterile
Prescription37%Rx‑only share
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Share of device records

Cynosure Lutronic Technology Corporation1916%
Classys Inc.1513%
Jeisys Medical Inc.1412%
Candela Corporation1311%
Lutronic Corporation87%
El.En. Spa65%
Beijing Adss Development Co., Ltd.54%
Solta Medical54%

Top labelers

CompanyDevicesShare
Cynosure Lutronic Technology Corporation1916%
Classys Inc.1513%
Jeisys Medical Inc.1412%
Candela Corporation1311%
Lutronic Corporation87%
El.En. Spa65%
Beijing Adss Development Co., Ltd.54%
Solta Medical54%
Ilooda.Co.,Ltd54%
Advanced Technology Laser Co.,Ltd.33%
Beijing Globalipl Development Co., Ltd.22%
Yoshida Dental Mfg. Co., Ltd., The22%

Company = labeler of record on GUDID. 30 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CO2 FRACTIONAL LASERMLKJHuameiSANOGlobaliplCO2 Laser Therapy SystemSWOTATLMONALIZAFractional CO2 Laser Therapy SystemCO2 Laser Therapy MachineGSDMedArt IntenzOpelaserFELS Laser SystemPhoenix CO2

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 Instrument116
ONGPowered Laser Surgical Instrument With Microbeam\Fractional 44
OUHSkin Resurfacing Rf Applicator12
GEIElectrosurgical, Cutting & Coagulation & Accessories12
GEXPowered laser surgical instrument2

GMDN & GCC registration

  • GMDN code 61473 · non‑implantable
  • Single‑use 5% · sterile 2% · Rx‑only 37% · 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

Weight (Kilogram) · 1Height (Centimeter) · 1Length (Centimeter) · 1Depth (Centimeter) · 1

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

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

119 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dermatological carbon dioxide laser system", from 30 companies. The largest labeler is Cynosure Lutronic Technology Corporation with 16% of records.

Which FDA product codes apply?

GEX (Powered Laser Surgical Instrument), ONG (Powered Laser Surgical Instrument With Microbeam\Fractional ), OUH (Skin Resurfacing Rf Applicator), GEI (Electrosurgical, Cutting & Coagulation & Accessories)

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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