# K023193: Candela Gentle Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Dec 20, 2002 after 86 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: 6 generations back to K910422 (1992). 36 ancestors in all.
656 later devices descend from it; 2 cite it directly.
0 of 693 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)
- K003147: Lyra Series Surgical Laser System (SL Series, ND:Yag Configuration), Laserscope (2000)
- K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models, Altus Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K033172: Candela Gentleyag Family of Laser Systems (2003), 654 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
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own

## Indications for use
The GentleYAG Laser System is intended for the treatment of Pseudofolliculitis Barbae.

Source page: https://510kreport.com/device/K023193
Methodology: https://510kreport.com/methodology