CORELEADER SCAR-DIMMER— 510(k) K111733

Name: FDA 510(k) clearance K111733
Creator: U.S. Food and Drug Administration
Published: 2011-09-22

Substantially Equivalent

Coreleader Biotech Co., Ltd.

FDA 510(k) clearance K111733 for CORELEADER SCAR-DIMMER, Substantially Equivalent on 2011-09-22. Applicant: Coreleader Biotech Co., Ltd.. Device class: 1.

Clearance details

Applicant: Coreleader Biotech Co., Ltd.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 2011-06-21
Decision date: 2011-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei, Taiwan, TW

Download summary PDF View on FDA.gov ↗

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