# K012071: Ent Laservision

- Pathway: 510(k) (Traditional)
- Applicant: Union Medical USA
- Decided: Dec 3, 2001 after 154 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ENT LaserVision is a device to be used in conjunction with the UM-L25 CO2 Laser in order to perform Ear surgeries such as fenestration of the tympanic membrane and Myringotomy, Federal Law restricts the use of this device by or on the order of 2 qualified physician only.

Source page: https://510kreport.com/device/K012071
Methodology: https://510kreport.com/methodology