# K983211: Centauri

- Pathway: 510(k) (Traditional)
- Applicant: Premier Laser Systems, Inc.
- Decided: Oct 9, 1998 after 25 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.
242 later devices descend from it; 1 cites it directly.
0 of 243 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
- K012127: Pulsemaster Erbium Dental Laser System (2001), 241 descendants of its own
- K021508: Opusduo EC Dental Laser System (2002), 240 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 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 Caries, Cavity Preparation, Modification or Etching of Enamel prior to acid etching, and Modification or Etching of Dentin prior to acid etching.

Source page: https://510kreport.com/device/K983211
Methodology: https://510kreport.com/methodology