# K950831: Alexlazr

- Pathway: 510(k) (Traditional)
- Applicant: Candela Laser Corp.
- Decided: May 26, 1995 after 91 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.
116 later devices descend from it; 2 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K950831
Methodology: https://510kreport.com/methodology