# K051399: Wavelight Auriga

- Pathway: 510(k) (Traditional)
- Applicant: Wavelight Laser Technologie AG
- Decided: Jun 30, 2005 after 30 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dornier Medilas H: named in the summary without a submission number
- (no number) Lumenis Versapulse Powersuite: named in the summary without a submission number
- (no number) convergent Omnipulse 30: named in the summary without a submission number
- (no number) Trimedyne Omnipulse: named in the summary without a submission number

## Most influential descendants
- K090776: Megapulse Laser System and Fibers (2009), 1 descendant of its own
- K122368: Waterlase Iplus All Tissue Laser (2013), 0 descendants of its own
- K060752: Acmi Dur-HL Laser Systems (2006), 0 descendants of its own

## Indications for use
The AURIGA Holmium Laser system is intended to be used in surgical procedures involving open and endoscopic (laparoscopic, hysteroscopic, bronchoscopic, gastroenteroscopic and colonoscopic) breaking up stones, cutting (f. e. strictures), ablation, vaporization, excision, incision and coagulation of tissue in the specialties as Urology, Pulmonology, Arthroscopy, Gastroenteroology, Gynecology, ENT (f. e. DCR), Lithotripsy, Orthopedics, Discectomy and General Surgery.

Source page: https://510kreport.com/device/K051399
Methodology: https://510kreport.com/methodology