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Device Explorer · FDA GUDID · GMDN 36150

General/multiple surgical frequency-doubled 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 to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coag

US‑registered devices218in commercial distribution
Companies16labelers on GUDID
Single‑use3%of device records
Sterile3%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Laseroptek Co.,Ltd7635%
Nidek Co.,Ltd.3516%
Lutronic Corporation3014%
Lightmed Corporation2311%
Cynosure, Llc146%
Iridex Corporation105%
Boston Scientific Corporation84%
Carl Zeiss Meditec Ag63%

Top labelers

CompanyDevicesShare
Laseroptek Co.,Ltd7635%
Nidek Co.,Ltd.3516%
Lutronic Corporation3014%
Lightmed Corporation2311%
Cynosure, Llc146%
Iridex Corporation105%
Boston Scientific Corporation84%
Carl Zeiss Meditec Ag63%
Alcon Laboratories, Inc.42%
Wontech Co.,Ltd31%
Shenzhen Peninsula Medical Group Co., Ltd.21%
American Medical Systems21%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Boston AestheticsScan Attachable delivery unit (900BQ)Scan slit lamp delivery unit (NIDEK SL)Scan Attachable delivery unit (SL130)Bio delivery unit (OMEGA 500)Slit lamp delivery unit (NIDEK SL)Attachable delivery unit (SL130)Yellow Laser PhotocoagulatorEndophotocoagulation Delivery UnitExpansion boxScan slit lamp delivery unit (SL-1800)Scan attachable delivery unit (900BQ)Scan attachable delivery unit (SL130)Scan attachable delivery unit (SL-1800)Scan attachable delivery unit (30SL/M)Attachable delivery unit (900BQ)

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 Instrument168
HQFLaser, Ophthalmic64
GEXPowered laser surgical instrument22
OYWLaser, cellulite appearance2
HGFSOURCE, ABORTION UNIT, VACUUM2
HQFLaser, ophthalmic2

GMDN & GCC registration

  • GMDN code 36150 · non‑implantable
  • Single‑use 3% · sterile 3% · Rx‑only 91% · 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

Weight (Kilogram) · 18

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

How many general/multiple surgical frequency-doubled solid-state laser system products are registered in the US?

218 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General/multiple surgical frequency-doubled solid-state laser system", from 16 companies. The largest labeler is Laseroptek Co.,Ltd with 35% of records.

Which FDA product codes apply?

GEX (Powered Laser Surgical Instrument), HQF (Laser, Ophthalmic), GEX (Powered laser surgical instrument), OYW (Laser, cellulite appearance)

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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