ME— 510(k) K123845

Substantially Equivalent

Syneron Beauty , Ltd.

FDA 510(k) clearance K123845 for ME, Substantially Equivalent on 2013-01-10. Applicant: Syneron Beauty , Ltd.. Device class: 2.

Clearance details

Applicant: Syneron Beauty , Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2012-12-13
Decision date: 2013-01-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Philedelphia, PA, 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.