# K955662: Candela Q-Switched Alexandrite Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Candela Laser Corp.
- Decided: Jun 14, 1996 after 185 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.
118 later devices descend from it; 3 cite it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Candela Q-Switched Alexandrite Laser (Models PLTL-1 and TL-1): named in the summary without a submission number
- (no number) Cynosure Photogenica T10 Tattoo Removal Laser: named in the summary without a submission number

## Most influential descendants
- K063073: Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems (2006), 114 descendants of its own
- K073534: Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems (2008), 113 descendants of its own
- K081324: Candela Family of Q-Switched Alexandrite Lasers (2008), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own

## Indications for use
This premarket notification is for the Candela Q-Switched Alexandrite Lasers intended for use in the treatment of pigmented lesions and tattoos.

Source page: https://510kreport.com/device/K955662
Methodology: https://510kreport.com/methodology