# K100194: Optical Integrity Laserguard Fibers

- Pathway: 510(k) (Traditional)
- Applicant: Optical Integrity, Inc.
- Decided: May 20, 2010 after 118 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
Longest line of descent: 7 generations back to K936109 (1994). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022338: Optical Integrity General Shaped Fiber, Optical Integrity, Inc. (2002) Summary page 1.
- (no number) Dornier Mvidelas laser EPS mode: named in the summary without a submission number

## Indications for use
The Optical Integrity General Shaped Fibers with LaserGuardTM are intended to be used as an accessory to a medical laser. For specific applications, refer to the Instructions for Use documentation Supplied with the laser system being used with the LaserGuardTM system.

Source page: https://510kreport.com/device/K100194
Methodology: https://510kreport.com/methodology