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Device Explorer · FDA GUDID · GMDN 61474

General/multiple surgical laser system beam guide, reusable

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 devices866in commercial distribution
Companies34labelers on GUDID
Single‑use33%of device records
Sterile69%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Transamerican Technologies International15618%
Optical Integrity Inc14417%
Innovaquartz Llc9311%
Quanta System Spa658%
Laser Peripherals, Llc405%
Lumenis Ltd.395%
Med -Fibers Inc.395%
Convergent Laser Technologies384%

Top labelers

CompanyDevicesShare
Transamerican Technologies International15618%
Optical Integrity Inc14417%
Innovaquartz Llc9311%
Quanta System Spa658%
Laser Peripherals, Llc405%
Lumenis Ltd.395%
Med -Fibers Inc.395%
Convergent Laser Technologies384%
Wisdom Medical Technology, Llc314%
Biolase, Inc.293%
Trimedyne, Inc.233%
Clinical Laserthermia Systems Ab223%

Company = labeler of record on GUDID. 34 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SlimLine™OtoLase™ Straight HPOtoLase™ Curved HPOtoLase™ Starter KitOtoLase™ FiberSS FiberLase™ HP-M 240 mm malleableSS FiberLase™ HP-M 300 mm malleableSS FiberLase™ HP-M 140 mm malleableSS FiberLase™ HP-M 90 mm malleableSS FiberLase™ Handpiece-M KitSS FiberLase™ HP-R 240 mm bent, straight tipSS FiberLase™ HP-R 240 mm bent, curved tipSS FiberLase™ HP-R 180 mm straight, straight tipSS FiberLase™ HP-R 180 mm straight, curved tipSS FiberLase™ HP-R 140 mm bent, straight tipSS FiberLase™ HP-R 140 mm straight, curved tip

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 Instrument821
GEXPowered laser surgical instrument178
ONONeurosurgical Laser With Mr Thermography5
FAJCystoscope and accessories, flexible/rigid2
GEIElectrosurgical, Cutting & Coagulation & Accessories2
KTIBRONCHOSCOPE ACCESSORY1

GMDN & GCC registration

  • GMDN code 61474 · non‑implantable
  • Single‑use 33% · sterile 69% · Rx‑only 70% · 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) · 201Length (Millimeter) · 36Lumen/Inner Diameter (Micrometer) · 1Length (Meter) · 1Lumen/Inner Diameter (Millimeter) · 1Angle (degree) · 1

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

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

866 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, reusable", from 34 companies. The largest labeler is Transamerican Technologies International with 18% of records.

Which FDA product codes apply?

GEX (Powered Laser Surgical Instrument), GEX (Powered laser surgical instrument), ONO (Neurosurgical Laser With Mr Thermography), FAJ (Cystoscope and accessories, flexible/rigid)

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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