UltraShape System— 510(k) K161952

Substantially Equivalent

Syneron Medical, Ltd.

FDA 510(k) clearance K161952 for UltraShape System, Substantially Equivalent on 2016-11-07. Applicant: Syneron Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Syneron Medical, Ltd.
Product code: Code OHV
Device class: Class 2
Regulation: 21 CFR 878.4590
Advisory panel: General, Plastic Surgery
Date received: 2016-07-15
Decision date: 2016-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam Illit, 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.