# K083142: Picasso Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Amd Lasers, LLC
- Decided: Mar 13, 2009 after 141 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: 4 generations back to K011041 (2001). 10 ancestors in all.
16 later devices descend from it; 3 cite 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)
- K030539: Lasersmile, Biolase Technology, Inc. (2003) Summary page 1.
- K021227: Softlase G2-Surgical Diode Laser System, Zap Lasers, LLC (2002) Summary page 1.
- K003385: Twilite, Twilite White, Biolase Technology, Inc. (2001) Summary page 1.
- K003440: Softlase - Surgical Diode Laser System, Zap Lasers, Inc. (2001) Summary page 1.
- K050453: Odyssey 2.4G, Denlaser Elite, Model 002-00050, Ivoclar Vivadent, Inc. (2005) Summary page 1.
- K062071: Prometey, Model G1-03, Spectrum International (2006) Summary page 1.
- (no number) Biolase DioLase Plus: named in the summary without a submission number

## Most influential descendants
- 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
- K230274: Medical Diode Laser (M2) (2023), 2 descendants of its own

## Indications for use
The Picasso is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: · Gingival troughing for crown impressions · Gingiveotomy · Gingivoplasty · Gigival incision and excision · Hemostasis and coagulation · Excisional and micisional biopsies · Exposure of unerupted teeth · Fibroma removal · Frenectomy and frenotomy · Implant recovery · Incision and drainage of abscess · Leukoplakia · Operculectomy · Oral papillectomies * Pulpotomy · Pulpotomy as an adjunct to root canal therapy · Reduction of gingival hypertrophy · Soft tissue crown lengthening · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa · Vestibuloplasty Laser periodontal procedures, including: * 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). · Laser soft tissue curettage * Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket. · Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium Tooth Whitening Indications: · Laser assisted whiteninglbleaching of teeth. · Light activation for bleaching materials for teeth whitening.

Source page: https://510kreport.com/device/K083142
Methodology: https://510kreport.com/methodology