# K152939: Picasso Plus, Picasso Lite Plus

- Pathway: 510(k) (Special)
- Applicant: Amd Group, LLC
- Decided: Nov 25, 2015 after 51 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: 5 generations back to K011041 (2001). 12 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083142: Picasso Laser System, Amd Lasers, LLC (2009) Summary page 5.
- K102359: Picasso/ Picasso Lite/ Picasso Perio, Amd Lasers, LLC (2011) Summary page 5.

## Most influential descendants
- 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
- K241791: Medical Diode Laser Systems (GBOX-6H,  GBOX-10D , GBOX-12D,  GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (2025), 1 descendant of its own

## Indications for use
The Picasso Plus / Picasso Lite Plus is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: Gingival troughing for crown impression; Gingivectomy; Gingivoplasty; Gingival incision and excision; Hemostasis and coagulation; Excisional and incisional 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; and Vestibuloplasty. Laser Periodontal Procedures, including: Sulcular debridement (curettage, 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); Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium; and Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium). Teeth Whitening Indications (Picasso Plus Only): Laser assisted whitening of teeth and Light activation for whitening materials for teeth whitening.

Source page: https://510kreport.com/device/K152939
Methodology: https://510kreport.com/methodology