# K073534: Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Apr 3, 2008 after 108 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: 9 generations back to K910422 (1992). 65 ancestors in all.
113 later devices descend from it; 1 cites it directly.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063073: Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems, Candela Corp. (2006) Summary page 1.
- K063074: Candela 3630 Laser System, Candela Corp. (2006) Summary page 1.
- K034030: Apogee Elite, Cynosure, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own

## Indications for use
The Candela Family of Q-Switched Alexandrite Laser (Alexi~zR) systems is indicated for the following uses: Pigmented Lesions Tattoos

Source page: https://510kreport.com/device/K073534
Methodology: https://510kreport.com/methodology