# K974586: Aurora Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Premier Laser Systems, Inc.
- Decided: Jul 15, 1998 after 218 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 K954316 (1995). 1 ancestor in all.
318 later devices descend from it; 2 cite it directly.
0 of 320 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954316: Aurora Surgical Diode Laser System W/Accessories, Premier Laser Systems, Inc. (1995) Summary page 3.

## Most influential descendants
- K991994: Twilight (1999), 280 descendants of its own
- K012511: Waterlase Millennium (2002), 246 descendants of its own
- K021508: Opusduo EC Dental Laser System (2002), 240 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own

## Indications for use
SULCULAR DEBRIDEMENT - REMOVAL OF DISEASED OR INFLAMED SOFT TISSUE IN THE PERIODONTAL POCKET. NOTE: This is an additional indication to the indications cleared for market release in 510(k) 954316.

Source page: https://510kreport.com/device/K974586
Methodology: https://510kreport.com/methodology