# K023547: Diolase 980 D Laser System

- Pathway: 510(k) (Traditional)
- Applicant: American Dental Technologies, Inc.
- Decided: Apr 15, 2003 after 176 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.
52 later devices descend from it; 1 cites it directly.
0 of 53 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 its predicate without a number.
- (no number) BioLitec Smilepro 980 nm Diode Laser: named in the summary without a submission number

## Most influential descendants
- K072262: Gentleray 980 Diode Laser System (2007), 51 descendants of its own
- K092660: Sirolaser Advance (2009), 27 descendants of its own
- K103753: Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, Fonalaser (2011), 26 descendants of its own
- K094049: Stlase Diode Laser (2010), 23 descendants of its own
- K111689: Stlase (2012), 22 descendants of its own

## Indications for use
The following indications for use are the same as those approved on the predicate device. The DioLase 980 D Diode Dental Laser System is intended for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Diseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.

Source page: https://510kreport.com/device/K023547
Methodology: https://510kreport.com/methodology