Consulting Wallah › Device Explorer › Ophthalmic › Ophthalmic diagnostic condensing lens
Device Explorer · FDA GUDID · GMDN 47946

Ophthalmic diagnostic condensing lens

An ophthalmic lens intended to be used during binocular indirect ophthalmoscopy and/or slit lamp examination to focus reflected light from the fundus of the eye. The lens is available in a variety of sizes and optical powers. This is a reusable device.

US‑registered devices356in commercial distribution
Companies7labelers on GUDID
Single‑use8%of device records
Sterile8%labelled sterile
Prescription7%Rx‑only share
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Share of device records

Ocular Instruments, Inc.18251%
Volk Optical Inc.12034%
Haag-Streit Ag278%
Oculus Surgical Inc175%
Katena Products, Inc.62%
Insight Instruments, Inc.31%
Glaukos Corporation10%

Top labelers

CompanyDevicesShare
Ocular Instruments, Inc.18251%
Volk Optical Inc.12034%
Haag-Streit Ag278%
Oculus Surgical Inc175%
Katena Products, Inc.62%
Insight Instruments, Inc.31%
Glaukos Corporation10%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SUPER VIEW® Disposable Wide Field Lens Set for RSUPER VIEW® Disposable Lens Set, PivotHD LenZ Pack Plus, for ZEISS RESIGHT®SUPER VIEW® Disposable Wide Field Lens for ZEISSSUPER VIEW Pack, HD, Disposable, for ZEISS RESIGSUPER VIEW® Disposable HD Lens Set for RESIGHT®SUPER VIEW® Disposable Lens Set for ZEISS RESIGHSUPER VIEW® Disposable Lens Set, EssentialSUPER VIEW® Disposable Lens Setiprism® CLIPGonio Ready 200 for f=200mmVERSA HD Disposable LenZVersa Optic Set, for f=200mmVersa Optic Set, for f=175mmSuper View® Lens Set, Disposable, Pivot, for BIOHD Disposable, LenZ

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

FDA product codes

CodeNameDevices
HJLLens, Condensing, Diagnostic320
HJKLens, Contact, Polymethylmethacrylate, Diagnostic34
HJLLens, condensing, diagnostic4
LROGeneral Surgery Tray3
HKSPrism, Gonioscopic1

GMDN & GCC registration

  • GMDN code 47946 · non‑implantable
  • Single‑use 8% · sterile 8% · Rx‑only 7% · 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 (Millimeter) · 21Width (Millimeter) · 3

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

How many ophthalmic diagnostic condensing lens products are registered in the US?

356 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ophthalmic diagnostic condensing lens", from 7 companies. The largest labeler is Ocular Instruments, Inc. with 51% of records.

Which FDA product codes apply?

HJL (Lens, Condensing, Diagnostic), HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic), HJL (Lens, condensing, diagnostic), LRO (General Surgery Tray)

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.

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