Consulting Wallah › Device Explorer › Ophthalmic › Laser lens, ophthalmic, surgical
Device Explorer · FDA GUDID · GMDN 40238

Laser lens, ophthalmic, surgical

A device designed to modify the convergence of the rays of light of an ophthalmic laser beam used to coagulate or cut tissues of the eye, the orbit, or the surrounding skin.

US‑registered devices106in commercial distribution
Companies2labelers on GUDID
Single‑use2%of device records
Sterile2%labelled sterile
Prescription52%Rx‑only share
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Share of device records

Ocular Instruments, Inc.6258%
Volk Optical Inc.4442%

Top labelers

CompanyDevicesShare
Ocular Instruments, Inc.6258%
Volk Optical Inc.4442%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TransEquator (VTE)Singh MidVitreous (VESMV)HR Wide Field (VEHRWF)Singh MidVitreous (VSMV)Idrees MidVitreous (VEIMV)Super Quad 160 (VESQUAD160)HR Centralis (VEHRC)Area Centralis (VEAC)Blumenthal Iridotomy (VEBIRID)Mag Plus Iridectomy (VEMPIRID)Iridectomy (VEIRID)Capsulotomy (VECAPS)Disposable Iridotomy (VIRIDD)Disposable Capsulotomy (VCAPSD)Idrees MidVitreous (VIMV)Blumenthal Iridotomy (VBIRID)

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

FDA product codes

CodeNameDevices
HJKLens, Contact, Polymethylmethacrylate, Diagnostic99
HKSPrism, Gonioscopic5
HJILens, Fundus, Hruby, Diagnostic2

GMDN & GCC registration

  • GMDN code 40238 · non‑implantable
  • Single‑use 2% · sterile 2% · Rx‑only 52% · 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.

How many laser lens, ophthalmic, surgical products are registered in the US?

106 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Laser lens, ophthalmic, surgical", from 2 companies. The largest labeler is Ocular Instruments, Inc. with 58% of records.

Which FDA product codes apply?

HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic), HKS (Prism, Gonioscopic), HJI (Lens, Fundus, Hruby, 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.

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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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