# K211979: Lumenis Y&R Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Jun 21, 2022 after 361 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: 13 generations back to K910422 (1992). 132 ancestors in all.
No later device cites it as a predicate yet.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063808: Fraxel IV SR Laser System, Reliant Technologies, Inc. (2007) Summary page 4.
- K130193: Fraxel Dual 1550/1927 Laser System, Solta Medical, Inc. (2013) Summary page 4.

## Indications for use
The YandR System, handpiece and accessories are intended for dermatological procedures requiring the coagulation of soft tissue as follows: 1410 nm Indications for Use: * Fractional skin resurfacing procedures 1927 nm Indications for Use * Fractional skin resurfacing procedures LPTT (Polytherapy) application of 1410 nm and 1927 nm simultaneously * Fractional skin resurfacing procedures

Source page: https://510kreport.com/device/K211979
Methodology: https://510kreport.com/methodology