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Device Explorer · FDA GUDID · GMDN 61162

Ophthalmic laser system beam guide

A sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists

US‑registered devices1,385in commercial distribution
Companies18labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Ophthalmed Llc81159%
Peregrine Surgical, Llc13210%
Fci S A S Fci 20 221158%
Iridex Corporation886%
Synergetics Usa, Inc.554%
Vortex Surgical, Inc.363%
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.272%
Katalyst Surgical Llc222%

Top labelers

CompanyDevicesShare
Ophthalmed Llc81159%
Peregrine Surgical, Llc13210%
Fci S A S Fci 20 221158%
Iridex Corporation886%
Synergetics Usa, Inc.554%
Vortex Surgical, Inc.363%
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.272%
Katalyst Surgical Llc222%
Vitreq B.V.212%
Alcon Laboratories, Inc.191%
Bausch & Lomb Incorporated161%
Ellex Medical Pty Ltd121%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LIQUID OPTICS INTERFACESterilized Endophoto Probe(25G/Coaxial)Sterilized Endophoto Probe(23G/Coaxial)Sterilized Endophoto Probe(20G/Coaxial)Sterilized Endophoto Probe(27G/Straight)Sterilized Endophoto Probe(25G/Angled)Sterilized Endophoto Probe(25G/Straight)Sterilized Endophoto Probe(23G/Angled)Sterilized Endophoto Probe(23G/Straight)Sterilized Endophoto Probe(20G/Angled)Sterilized Endophoto Probe(20G/Straight)FiberTech®FCI directional LASER PROBE 23G QUANTELBeamPath OTO-M fiberBeamPath OTO-S fiberBVI

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
HQFLaser, Ophthalmic1,274
HQBPhotocoagulator And Accessories401
GEXPowered Laser Surgical Instrument210
HQFLaser, ophthalmic152
MPAEndoilluminator74
GEXPowered laser surgical instrument49

GMDN & GCC registration

  • GMDN code 61162 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 96% · 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

Needle Gauge (Gauge) · 1,591

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

How many ophthalmic laser system beam guide products are registered in the US?

1,385 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic laser system beam guide", from 18 companies. The largest labeler is Ophthalmed Llc with 59% of records.

Which FDA product codes apply?

HQF (Laser, Ophthalmic), HQB (Photocoagulator And Accessories), GEX (Powered Laser Surgical Instrument), HQF (Laser, ophthalmic)

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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