# K992620: Blulaze

- Pathway: 510(k) (Traditional)
- Applicant: Premier Laser Systems, Inc.
- Decided: Aug 20, 1999 after 15 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
Curing of all light cured bonding materials Curing of pit and fissure sealants (unfilled resins) Curing for all classes of composite restorations (filled resins) Curing for endodontic composite cores Curing composite cements for porcelain facings and inlays Curing of light activated periodontal splint material Curing of light activated prosthetic reline and repair material Curing use in the fabrication of laboratory indirect light activated and provisional restorations Teeth Whitening

Source page: https://510kreport.com/device/K992620
Methodology: https://510kreport.com/methodology