# K971118: ARAGO

- Pathway: 510(k) (Traditional)
- Applicant: Premier Laser Systems, Inc.
- Decided: Dec 16, 1997 after 270 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K983654: Cyber-Lase 2000 Curing and Whitening Laser (1999), 0 descendants of its own

## Indications for use
1. Curing of all light cured bonding materials. 2. Curing of pit and fissure sealants (unfilled resins). 3. Curing for all classes of composite restorations (filled resins). 4 Curing for endodontic composite cores. 5. Curing composite cements for porcelain facings and inlays. 6. Curing of light activated periodontal splint material. 7. Curing of light activated prosthetic reline and repair material. 8. Curing used in the fabrication of laboratory indirect light activated restorations and provisional restorations. 9. Illumination purposes for the adjunctive use in caries detection. 10. Tllumination purposes for the adjunctive use for endodontic orifice location. 11. Light activation for bleaching materials for teeth whitening.

Source page: https://510kreport.com/device/K971118
Methodology: https://510kreport.com/methodology