# K970157: Laserscope Automatic Eye Protection Filter

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Apr 7, 1997 after 81 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Automatic Eye Protection Filter which is an integral part of the Laserscope 800 Series Surgical Laser System: named in the summary without a submission number

## Indications for use
The Laserscope Automatic Eye Protection Filter is intended to be used in conjunction with an endoscope or microscope for all cleared Laserscope indications for the Orion and Aura Surgical Laser Systems.

Source page: https://510kreport.com/device/K970157
Methodology: https://510kreport.com/methodology