Intense Pulsed Light System— 510(k) K231394

Name: FDA 510(k) clearance K231394
Creator: U.S. Food and Drug Administration
Published: 2023-08-09

Substantially Equivalent

Smedtrum Medical Technology Co., Ltd.

FDA 510(k) clearance K231394 for Intense Pulsed Light System, Substantially Equivalent on 2023-08-09. Applicant: Smedtrum Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Smedtrum Medical Technology Co., Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2023-05-15
Decision date: 2023-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, 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.