# K972325: Pulsemaster 1000 ST Dental Laser System

- Pathway: 510(k) (Traditional)
- Applicant: American Dental Technologies, Inc.
- Decided: Sep 19, 1997 after 88 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 K922901 (1992). 2 ancestors in all.
318 later devices descend from it; 2 cite it directly.
0 of 321 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922901: Incisor I Pulsed ND:Yag Laser System, Buckman Co., Inc. (1992) Summary page 1.
- K954316: Aurora Surgical Diode Laser System W/Accessories, Premier Laser Systems, Inc. (1995) Summary page 1.

## Most influential descendants
- K991994: Twilight (1999), 280 descendants of its own
- K012511: Waterlase Millennium (2002), 246 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

## Indications for use
The PulseMaster® 1000 ST Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is indicated for use in the following procedures: lesion (tumor) removal biopsies fibroma removal frenectomies and frenotomies gingivoplasties gingivectomies leukoplakia operculectomies oral papillectomies aphthous ulcers sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility.

Source page: https://510kreport.com/device/K972325
Methodology: https://510kreport.com/methodology