# K951034: Aura Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Apr 13, 1995 after 38 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.
314 later devices descend from it; 8 cite it directly.
0 of 315 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
- K954905: CB Diode/532 Laser System (1996), 308 descendants of its own
- 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

Source page: https://510kreport.com/device/K951034
Methodology: https://510kreport.com/methodology