# K022951: Candela Gentle Yag Laser System, Variable Pulse Yag

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Jan 27, 2003 after 144 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: 2 generations back to K000811 (2000). 4 ancestors in all.
657 later devices descend from it; 4 cite it directly.
0 of 662 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010104: Candela Long Pulse ND:Yag, Candela Corp. (2001)
- K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration), Laserscope (2002)

## Most influential descendants
- K033172: Candela Gentleyag Family of Laser Systems (2003), 654 descendants of its own
- K033251: The Friendlylight ND: Yag Lasers (2004), 519 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K040617: Reliant Laser System II (2004), 316 descendants of its own
- K042319: Reliant Laser II System and Accessories (2005), 284 descendants of its own

## Indications for use
The Candela GentleYAG Laser System is intended for the treatment of facial wrinkles.

Source page: https://510kreport.com/device/K022951
Methodology: https://510kreport.com/methodology