# K012127: Pulsemaster Erbium Dental Laser System

- Pathway: 510(k) (Traditional)
- Applicant: American Dental Technologies, Inc.
- Decided: Oct 4, 2001 after 87 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
Longest line of descent: 1 generation back to K983211 (1998). 3 ancestors in all.
241 later devices descend from it; 1 cites it directly.
0 of 245 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983211: Centauri, Premier Laser Systems, Inc. (1998) Summary page 1.
- K992013: DEL2940 Dental Erbium Laser, Delite Dental Erbium Laser, Continuum Biomedical, Inc. (1999) Summary page 1.
- K001527: Fotona Fidelis ER: Yag Laser System and Accesories, Fotona D.D. (2000) Summary page 1.

## Most influential descendants
- 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
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own

## Indications for use
The PulseMaster Erbium Dental laser System is intended for the removal of caries and cavity preparation for primary and secondary teeth, the modification and etching of enamel and dentin prior to acid etching, and the incision, excision, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery including, but not limited to, gingival tissues.

Source page: https://510kreport.com/device/K012127
Methodology: https://510kreport.com/methodology