# K070296: Visiolite Ophthalmic ER: Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Ace Vision Group
- Decided: Oct 3, 2007 after 245 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: 10 generations back to K910422 (1992). 179 ancestors in all.
No later device cites it as a predicate yet.
0 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052354: Oculase MD, Biolase Technology, Inc. (2006) Summary page 1.
- K971843: Laserscope Vela Erbium:Yag Laser System and Accessories, Laserscope (1997) Summary page 1.

## Indications for use
The VisioLite® is indicated for the ophthalmic soft tissue surrounding the eye and orbit.

Source page: https://510kreport.com/device/K070296
Methodology: https://510kreport.com/methodology