# K094049: Stlase Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Dental Photonics, Inc.
- Decided: Sep 10, 2010 after 253 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: 16 generations back to K943450 (1995). 188 ancestors in all.
23 later devices descend from it; 1 cites it directly.
0 of 212 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081015: Ceralas D 980NM Diode Laser, Models D15 and D25, Biolitec, Inc. (2008) Summary page 1.
- K072262: Gentleray 980 Diode Laser System, Kavo America (2007) Summary page 1.
- K982629: Dornier Medilas D, Dornier Surgical Products, Inc. (1998) Summary page 1.

## Most influential descendants
- K111689: Stlase (2012), 22 descendants of its own
- K163128: Epic Pro (2017), 16 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K122020: Photon Photon Plus (2013), 4 descendants of its own
- K202991: Fotona XPulse Pro Laser Platform (2021), 3 descendants of its own

## Indications for use
The stLaSe TM with surgical laser operation that can be used in contact or non-contact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue, and The stLaseTm with dental laser operation that can be used in contact or non-contact technique is intended for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdlental gingiva and epithelial lining of free gingiva). Examples include: 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, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy, and light activation of bleaching materials for teeth whitening.

Source page: https://510kreport.com/device/K094049
Methodology: https://510kreport.com/methodology