Diode Laser Body Sculpture System— 510(k) K201731

Name: FDA 510(k) clearance K201731
Creator: U.S. Food and Drug Administration
Published: 2020-09-10

Substantially Equivalent

Shanghai Apolo Medical Technology Co., Ltd.

FDA 510(k) clearance K201731 for Diode Laser Body Sculpture System, Substantially Equivalent on 2020-09-10. Applicant: Shanghai Apolo Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Apolo Medical Technology Co., Ltd.
Product code: Code PKT
Device class: Class 2
Regulation: 21 CFR 878.5400
Advisory panel: General, Plastic Surgery
Date received: 2020-06-24
Decision date: 2020-09-10
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.