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Laserscope Automatic Eye Protection Filter

by Laserscope

510(k) K970157

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 NumberK970157 Date7 Apr 1997ClearedStatusActive

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  • Withdrawn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
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Laserscope Automatic Eye Protection Filter is a powered laser surgical instrument that provides automatic eye protection by moving protective filters into the line of view before laser emission. It is designed to be used in conjunction with an endoscope or microscope. The device features a mechanical shutter system that is activated via a laser foot pedal, providing an unobstructed view when the laser is inactive.

The Laserscope Automatic Eye Protection Filter is supplied for use with the Orion and Aura Surgical Laser Systems. It is classified as a Class II device with special controls and has been cleared under the FDA 510(k) process with the clearance number K970157. The device is intended to provide eye protection during laser procedures.

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Questions

AI-generated answers, 6 Oct 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 Laserscope Automatic Eye Protection Filter used for?

    The Laserscope Automatic Eye Protection Filter is used to provide eye protection during laser procedures by moving protective filters into the line of view before laser emission.

  • How is the Laserscope Automatic Eye Protection Filter activated?

    The device is activated via a laser foot pedal, providing an unobstructed view when the laser is inactive.

  • Is the Laserscope Automatic Eye Protection Filter compatible with other laser systems?

    The Laserscope Automatic Eye Protection Filter is supplied for use with the Orion and Aura Surgical Laser Systems.