Profound System— 510(k) K161043

Substantially Equivalent

Syneron Candela Corporation

FDA 510(k) clearance K161043 for Profound System, Substantially Equivalent on 2016-09-12. Applicant: Syneron Candela Corporation. Device class: 2.

Clearance details

Applicant: Syneron Candela Corporation
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2016-04-13
Decision date: 2016-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayland, MA, US

Download summary PDF View on FDA.gov ↗

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