Consulting Wallah › Device Explorer › Ophthalmic › Ophthalmic fibreoptic light instrument, single-use
Device Explorer · FDA GUDID · GMDN 45193

Ophthalmic fibreoptic light instrument, single-use

A sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected th

US‑registered devices365in commercial distribution
Companies12labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription71%Rx‑only share
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Share of device records

Katalyst Surgical Llc11331%
Synergetics Usa, Inc.6518%
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.5816%
Peregrine Surgical, Llc5214%
Vitreq B.V.236%
Bausch & Lomb Incorporated144%
Microvision, Inc.123%
Fci S A S Fci 20 22113%

Top labelers

CompanyDevicesShare
Katalyst Surgical Llc11331%
Synergetics Usa, Inc.6518%
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.5816%
Peregrine Surgical, Llc5214%
Vitreq B.V.236%
Bausch & Lomb Incorporated144%
Microvision, Inc.123%
Fci S A S Fci 20 22113%
Escalon Medical Corp.103%
Vortex Surgical, Inc.51%
Lightmed Usa Inc10%
Medimax Tech Inc.10%

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

Brand names on the register (sample)

Fiber Optic Light GuideCyclophotocoagulation Probe25ga Endo-Ocular Probes-Flexible Illuminated23ga Endo-Ocular Probes-Flexible Illuminated20ga Endo-Ocular Probe- Curved, Alcon Compatible20ga Endo-Ocular Probe- Curved, Iridex Compatibl20ga Endo-Ocular Probe- Curved25ga Endo-Ocular Probes Steerable, Alcon Compati25ga Endo-Ocular Probes Steerable, Iridex Compat25ga Endo-Ocular Probes Steerable23ga Endo-Ocular Probes Steerable, Alcon Compati23ga Endo-Ocular Probes Steerable, Iridex Compat23ga Endo-Ocular Probes Steerable27ga Laser Probe OS4, Flexible Curved25ga Endo-Ocular Probe- Flexible Curved, Quantel25ga Endo-Ocular Probe- Flexible Curved, Iridex

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

FDA product codes

CodeNameDevices
HQFLaser, Ophthalmic229
MPAEndoilluminator180
HQCUnit, Phacofragmentation23
HQBPhotocoagulator And Accessories16
HJMTransilluminator, ac-powered13
FFSImage, Illumination, Fiberoptic, For Endoscope 12

GMDN & GCC registration

  • GMDN code 45193 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 71% · 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) · 52Outer Diameter (Millimeter) · 12

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

How many ophthalmic fibreoptic light instrument, single-use products are registered in the US?

365 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic fibreoptic light instrument, single-use", from 12 companies. The largest labeler is Katalyst Surgical Llc with 31% of records.

Which FDA product codes apply?

HQF (Laser, Ophthalmic), MPA (Endoilluminator), HQC (Unit, Phacofragmentation), HQB (Photocoagulator And 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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