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Ophthalas Dye Ophthalmic Laser

by Biophysic Medical, Inc.

510(k) K873460

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK873460 Date29 Oct 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HQF
Device Class
Class II
Regulation
21 CFR Part 886.4390
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ophthalas Dye Ophthalmic Laser is a Class II ophthalmic laser device designed for coagulating or cutting ocular tissue. It emits a laser beam to perform precise surgical procedures on the eye, orbit, or adjacent skin, facilitating treatments such as retinal photocoagulation or vascular ablation.

This device is supplied as a reusable, AC-powered system and is regulated under FDA 510(k) clearance (K873460) with a decision of Substantially Equivalent. It is intended for use in clinical settings by trained ophthalmic professionals and adheres to regulatory standards outlined in 21 CFR 886.4390. No specific sterility or MRI safety information is provided in the available data.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Ophthalas Dye Ophthalmic Laser intended for?

    The Ophthalas Dye Ophthalmic Laser is designed for coagulating or cutting ocular tissue, enabling precise surgical procedures on the eye, orbit, or adjacent skin, such as retinal photocoagulation or vascular ablation, as stated in its description.

  • How is the Ophthalas Dye Ophthalmic Laser supplied and powered?

    The device is supplied as a reusable, AC-powered system, meaning it is intended for repeated use after appropriate cleaning and maintenance, and requires connection to an alternating current power source for operation.

  • What regulatory pathway was used for the Ophthalas Dye Ophthalmic Laser?

    The device received FDA 510(k) clearance under submission K873460, with a decision of Substantially Equivalent, indicating it was found to be substantially equivalent to a legally marketed predicate device.

  • Is the Ophthalas Dye Ophthalmic Laser sterile or single-use?

    The device is described as reusable, which implies it is not supplied sterile nor intended for single-use; instead, it is designed for multiple uses following proper reprocessing between patients.

  • What regulatory standard applies to the Ophthalas Dye Ophthalmic Laser?

    The device adheres to regulatory standards outlined in 21 CFR 886.4390, which governs ophthalmic lasers, as specified in the device data.