Forma System, Forma Light System— 510(k) K160195

Name: FDA 510(k) clearance K160195
Creator: U.S. Food and Drug Administration
Published: 2016-04-15

Substantially Equivalent

Formatk Systems , Ltd.

FDA 510(k) clearance K160195 for Forma System, Forma Light System, Substantially Equivalent on 2016-04-15. Applicant: Formatk Systems , Ltd.. Device class: 2.

Clearance details

Applicant: Formatk Systems , Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2016-01-27
Decision date: 2016-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat Carmel, IL

Download summary PDF View on FDA.gov ↗

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