TANDA MINI SKINCARE SYSTEM— 510(k) K124042

Name: FDA 510(k) clearance K124042
Creator: U.S. Food and Drug Administration
Published: 2013-04-02

Substantially Equivalent

Syneron Beauty

FDA 510(k) clearance K124042 for TANDA MINI SKINCARE SYSTEM, Substantially Equivalent on 2013-04-02. Applicant: Syneron Beauty. Device class: 2.

Clearance details

Applicant: Syneron Beauty
Product code: Code OLP
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2012-12-28
Decision date: 2013-04-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Philedelphia, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OLP

product code OLP

Other: 1
Total: 1

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.