Fiber Laser Treatment System— 510(k) K221770

Name: FDA 510(k) clearance K221770
Creator: U.S. Food and Drug Administration
Published: 2022-10-13

Substantially Equivalent

Shanghai Apolo Medical Technology Co., Ltd.

FDA 510(k) clearance K221770 for Fiber Laser Treatment System, Substantially Equivalent on 2022-10-13. Applicant: Shanghai Apolo Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Apolo Medical Technology Co., Ltd.
Product code: Code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2022-06-21
Decision date: 2022-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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