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Biophysic Medical, Inc.

United StatesFDA applicant, unverified

Devices
11

What Biophysic Medical, Inc. makes

Biophysic Medical, Inc. manufactures ophthalmic laser systems and accessories, including argon/dye laser devices with four specific modifications, an indirect ophthalmoscope accessory delivery system, and various endocular probes for diagnostic imaging. Their portfolio also includes standalone ophthalmic lasers such as the Nanolas Nd:YAG laser and Ophthecan imaging systems (Mini-B, B, and S Mini-A models). The company produces sterile disposable probes and interconnection components for laser systems, as well as ophthalmic dyes for laser procedures.

The company’s devices are regulated under FDA Class II and Class III classifications, with most products requiring 510(k) clearance. These products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

Newest first, rows 1-11 of 11

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  • Needle Or Cutter Ref K953399

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Paxial Ref K853116

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Indirect Ophthalmoscope Accessory Delivery System Ref K890509

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sterile Disposable Endocular Probe Ref K884456

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ophthalas Dye Ophthalmic Laser Ref K873460

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Interconn. Of Ophthalas & Nanolas Laser System Ref K883719

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Four Modifications To Ophthalas Argon/Dye Laser Ref K881494

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ophthascan Mini-B Ref K884595

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ophthascan B Ref K844686

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ophthascan 's' Mini-A Ref K893035

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Nanolas Nd:yag Ophthalmic Laser Ref K881459

    Active Regimes: 510(k) Registry: 510(k) Class:III

Rows 1-11 of 11

Frequently asked questions

How many devices does Biophysic Medical, Inc. have in the registry?

The registry currently lists 11 devices for Biophysic Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Biophysic Medical, Inc.'s devices?

Among its 11 most recently registered devices, Biophysic Medical, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Biophysic Medical, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Biophysic Medical, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from Biophysic Medical, Inc. in the registry?

The most recently registered devices listed for Biophysic Medical, Inc. include NEEDLE OR CUTTER, PAXIAL, INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM and STERILE DISPOSABLE ENDOCULAR PROBE.

Generated automatically from registry data and not verified by a human reviewer.