# K983524: Lares Research Sunlase 800P Laser System (to BE Sold as Peiolase for Laserenap)

- Pathway: 510(k) (Traditional)
- Applicant: Lares Research, Inc.
- Decided: Apr 1, 1999 after 175 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Sunlase 800P is indicated for incising, excising and coagulating intraoral soft tissue, including the marginal and interdental gingiva. This includes incising, excising and coagulating the epithelium lining, the free or marginal gingiva, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

Source page: https://510kreport.com/device/K983524
Methodology: https://510kreport.com/methodology