Picasso Plus, Picasso Lite Plus— 510(k) K152939

Name: FDA 510(k) clearance K152939
Creator: U.S. Food and Drug Administration
Published: 2015-11-25

Substantially Equivalent

Amd Group, LLC

FDA 510(k) clearance K152939 for Picasso Plus, Picasso Lite Plus, Substantially Equivalent on 2015-11-25. Applicant: Amd Group, LLC. Device class: 2.

Clearance details

Applicant: Amd Group, LLC
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2015-10-05
Decision date: 2015-11-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.