Gonioscope — 220 US-registered devices, 4 companies, FDA product codes | Device Explorer

Name: Gonioscope — US-registered devices
Creator: Consulting Wallah
License: https://creativecommons.org/licenses/by-nc-nd/4.0/

Share of device records

Ocular Instruments, Inc.17077%

Volk Optical Inc.3817%

Med Saver, Inc.115%

Katena Products, Inc.10%

Top labelers

Company	Devices	Share
Ocular Instruments, Inc.	170	77%
Volk Optical Inc.	38	17%
Med Saver, Inc.	11	5%
Katena Products, Inc.	1	0%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Single Use GonioPro Surgical Lens Sample Box (VSSingle Use GonioPro Surgical Lens + Handle (VSGLSingle Use GonioPro Surgical Lens + Multi-Port SSingle Use GonioPro Surgical Lens + Single-Port Single Use GonioPro Surgical Multi-Port StabilizSingle Use GonioPro Surgical Single-Port StabiliGonioPro Surgical Lens + Handle (VSGLHACS)Rapid SLTVolk Vold Surgical Gonio LensSingle Use SLTSingle Use 3-Mirror GonioSingle Use 4-Mirror GonioAlcon Vold TVG Surgical GonioSurgical GoniotomyMini 4 Mirror ANF+SLT

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

FDA product codes

Code	Name	Devices
HKS	Prism, Gonioscopic	204
HKS	Prism, gonioscopic	12
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic	4

GMDN & GCC registration

GMDN code 11894 · non‑implantable
Single‑use 5% · sterile 5% · Rx‑only 6% · 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

No structured size data on the register.

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

No closely related category with 50+ devices.

How many gonioscope products are registered in the US?

220 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gonioscope", from 4 companies. The largest labeler is Ocular Instruments, Inc. with 77% of records.

Which FDA product codes apply?

HKS (Prism, Gonioscopic), HKS (Prism, gonioscopic), HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic)

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.

How do I get quotes?

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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.