# K102359: Picasso/ Picasso Lite/ Picasso Perio

- Pathway: 510(k) (Abbreviated)
- Applicant: Amd Lasers, LLC
- Decided: Sep 16, 2011 after 393 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.
20 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K152939: Picasso Plus, Picasso Lite Plus (2015), 12 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
- K162114: Photon, Photon Plus (2016), 3 descendants of its own

## Indications for use
The Picasso TM/Picasso Lite TM/ Picasso PerioTM isgenerally 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 papillectomnies * 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 debridernent (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. Teeth Whitening Indications (Picasso Only): * Laser assisted whiten ing/bleach ing of teeth * Light activation for bleaching materials for teeth whitening. In addition to the aforementioned indications of use previously cleared by the FDA, the following indication is requested to be added: Laser periodontal: Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).

Source page: https://510kreport.com/device/K102359
Methodology: https://510kreport.com/methodology