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Device Explorer · FDA GUDID · GMDN 62600

General/multiple surgical laser system beam guide, single-use

A surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasi

US‑registered devices399in commercial distribution
Companies27labelers on GUDID
Single‑use97%of device records
Sterile97%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Optical Integrity Inc6416%
Convergent Laser Technologies4511%
Trimedyne, Inc.338%
Ceram Optec Sia267%
Oberon Gmbh Fiber Technologies256%
Gyrus Acmi, Llc195%
Asclepion Laser Technologies Gmbh174%
Lumenis Ltd.164%

Top labelers

CompanyDevicesShare
Optical Integrity Inc6416%
Convergent Laser Technologies4511%
Trimedyne, Inc.338%
Ceram Optec Sia267%
Oberon Gmbh Fiber Technologies256%
Gyrus Acmi, Llc195%
Asclepion Laser Technologies Gmbh174%
Lumenis Ltd.164%
Clinicon Corporation164%
Boston Scientific Corporation154%
Dornier Medtech America, Inc.144%
Ipg Medical Corporation133%

Company = labeler of record on GUDID. 27 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SlimLine™Xpeeda™ ENDO D/S/LMoses™SlimLine™ 200 D/F/L LPSlimLine™ SIS EZ 200 LPSS FiberLase™ Accessory Starter Kit with FiberLaFiberLase™ CO2 FiberneoLaser Laser Surgery FiberHemolase FiberHalo Sterile Single-use Radial Fibertamburo Thulium Laser FiberLaser Surgery Fibers and ProbesBare Fiber HB 2.1. 272Bare Fiber H 2.1 200Bare Fiber B 2.1 272 4,5mBare Fiber B 2.1 365 4,5m

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 Instrument373
GEXPowered laser surgical instrument41

GMDN & GCC registration

  • GMDN code 62600 · non‑implantable
  • Single‑use 97% · sterile 97% · Rx‑only 88% · 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

Outer Diameter (Micrometer) · 67Length (Centimeter) · 10Length (Meter) · 10Outer Diameter (Meter) · 1

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

How many general/multiple surgical laser system beam guide, single-use products are registered in the US?

399 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General/multiple surgical laser system beam guide, single-use", from 27 companies. The largest labeler is Optical Integrity Inc with 16% of records.

Which FDA product codes apply?

GEX (Powered Laser Surgical Instrument), GEX (Powered laser surgical instrument)

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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