# K933841: Centauri

- Pathway: 510(k) (Traditional)
- Applicant: Premier Laser Systems, Inc.
- Decided: May 5, 1997 after 1,370 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. The FDA summary names no predicate by number.

## Most influential descendants
- K983868: Opmi Twiner Surgical Microscope (1999), 0 descendants of its own

## Indications for use
The laser is indicated for Incision, Excision, Hemostasis, Ablation of Tissue, and Vaporization of Tissue in the oral cavity. The additional representative indications include Removal of Canes, Cavity Preparation, Modification or Etching of Eramel prior to acid etching, and Modification or Etching of Dentin prior to acid etching. The conrraindicanons are for children under the age of 18 years.

Source page: https://510kreport.com/device/K933841
Methodology: https://510kreport.com/methodology