BETA
Ophthalmic diagnostic and surgical lenses, visualization systems and retinal imaging tools.
Volk Optical develops ophthalmic lenses and imaging tools for examination and treatment of the eye. Its portfolio includes contact and non-contact diagnostic lenses, surgical viewing systems and handheld retinal-imaging products, serving clinicians through direct and distributor channels.
The company operates from Mentor, Ohio, and is part of Halma’s healthcare businesses. Natalya Shaykevich is its current President. The commercial portfolio spans reusable and single-use products, whose cleaning requirements, intended uses and regulatory pathways differ.
This selected review links FDA’s disposable iridotomy and capsulotomy lens decision to that specific lens family. It does not assign the same clearance to every Volk lens or camera. Commercial reach and the breadth of ophthalmic workflow support are the main profile themes.
Volk’s ophthalmic lens portfolio has several FDA 510(k) decisions, including diagnostic/contact-lens history absent from the previous snapshot. A listing for an OEM camera does not establish that every visualization product shares the same authorization or exemption. [21][22][18][6][5][23][1]
The matched FDA history contains 6 distinct recall events: 0 open, 6 terminated. 0 were initiated during the five years beginning October 20, 2021; older open events are also retained. Z-1177-2016 (2016-02-02; terminated): The firm discovered that the incorrect lot number was engraved on the product. Z-1685-2015 (2015-02-27; terminated): Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. Z-2055-2015 (2015-02-27; terminated): Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error. [13][11][12]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Procedure-specific contact lens family for ophthalmic laser procedures. [22][18]
FDA-clearedCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Commercial diagnostic and surgical optics; individual model authorizations are not fully mapped. [21]
Marketed · regulatory scope variesCommercially offered; exact model and country availability should be confirmed with the manufacturer.
Commercial ophthalmic portfolio with one directly matched disposable-lens decision; no blanket exemption or approval asserted. [21][22][18]
Accessed 10/20/2026