# K062071: Prometey, Model G1-03

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum International
- Decided: Sep 28, 2006 after 69 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: 3 generations back to K011041 (2001). 9 ancestors in all.
17 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050453: Odyssey 2.4G, Denlaser Elite, Model 002-00050, Ivoclar Vivadent, Inc. (2005) Summary page 1.
- K030539: Lasersmile, Biolase Technology, Inc. (2003) Summary page 1.
- K021227: Softlase G2-Surgical Diode Laser System, Zap Lasers, LLC (2002) Summary page 1.

## Most influential descendants
- K083142: Picasso Laser System (2009), 16 descendants of its own
- K152939: Picasso Plus, Picasso Lite Plus (2015), 12 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K202991: Fotona XPulse Pro Laser Platform (2021), 3 descendants of its own
- K240179: Medical Diode Laser (Model: L2) (2024), 2 descendants of its own

## Indications for use
Dental Soft Tissue Indications for incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: Excision and Incision Biopsies, Hemostasis and Coagulation, Treatment of canker sores, herpetic and aphthous ulcers, Frenectomy and Frenotomy, Gingival Incision and Excision, Gingivectomy and Gingivoplasty, Incision and Drainage of Abscess, Operculectomy, Oral Papillectomy, Removal of Fibromas and Hyperplastic tissues, Exposure of un-erupted / partially erupted teeth, Implant recovery, Tissue retraction / troughing, Leukoplakia, Pulpotomy, Soft tissue crown lengthening, Vestibuloplasty. Laser Periodontal Procedures, including: Laser soft tissue curettage, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility). Teeth Whitening Procedures, including: Light Activation of bleaching materials for teeth whitening, Laser-assisted whitening / bleaching of teeth.

Source page: https://510kreport.com/device/K062071
Methodology: https://510kreport.com/methodology