# K954905: CB Diode/532 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Continuum Biomedical, Inc.
- Decided: Mar 29, 1996 after 156 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: 1 generation back to K933880 (1994). 2 ancestors in all.
308 later devices descend from it; 3 cite it directly.
0 of 311 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951034: Aura Laser System, Laserscope (1995) Summary page 1.
- K933880: SL Series Surgical Laser Systems, Laserscope (1994) Summary page 1.

## Most influential descendants
- K964074: Diolite 532 (1997), 307 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K103118: Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor (2010), 92 descendants of its own
- K020071: Viridis Derma Laser (2002), 92 descendants of its own

## Indications for use
Treatment of cutaneous vascular and pigmented lesions.

Source page: https://510kreport.com/device/K954905
Methodology: https://510kreport.com/methodology