Diode Laser Body Sculpture Systems— 510(k) K231131

Name: FDA 510(k) clearance K231131
Creator: U.S. Food and Drug Administration
Published: 2023-06-22

Substantially Equivalent

Shanghai Bele Medical Technology Co.,Ltd

FDA 510(k) clearance K231131 for Diode Laser Body Sculpture Systems, Substantially Equivalent on 2023-06-22. Applicant: Shanghai Bele Medical Technology Co.,Ltd. Device class: 2.

Clearance details

Applicant: Shanghai Bele Medical Technology Co.,Ltd
Product code: Code PKT
Device class: Class 2
Regulation: 21 CFR 878.5400
Advisory panel: General, Plastic Surgery
Date received: 2023-04-21
Decision date: 2023-06-22
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.