# K060459: Quadrostar 980

- Pathway: 510(k) (Special)
- Applicant: Asclepion Laser Technologies GmbH
- Decided: Mar 20, 2006 after 26 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Ceralas D 980: named in the summary without a submission number

## Indications for use
The QuadroStar 980 Laser System is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers or catheters. The QuadroStar 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery cardiothoracic surgery. This QuadroStar 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).

Source page: https://510kreport.com/device/K060459
Methodology: https://510kreport.com/methodology