# K162556: Lightfusion Led System

- Pathway: 510(k) (Traditional)
- Applicant: Vitage Led, Ltd.
- Decided: Mar 24, 2017 after 191 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: 18 generations back to K943450 (1995). 254 ancestors in all.
No later device cites it as a predicate yet.
0 of 255 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124064: Young Again, Espansione Marketing S.P.A (2013) Summary page 5.

## Indications for use
The proposed intended use of the Lightfusion™ LED system is to emit energy in the RED and Near Infra-Red (NIR) regions of the spectrum and is indicated for the treatment of periorbital wrinkles.

Source page: https://510kreport.com/device/K162556
Methodology: https://510kreport.com/methodology