Diosculpt— 510(k) K222265

Name: FDA 510(k) clearance K222265
Creator: U.S. Food and Drug Administration
Published: 2022-09-23

Substantially Equivalent

Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

FDA 510(k) clearance K222265 for Diosculpt, Substantially Equivalent on 2022-09-23. Applicant: Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. Device class: 2.

Clearance details

Applicant: Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
Product code: Code PKT
Device class: Class 2
Regulation: 21 CFR 878.5400
Advisory panel: General, Plastic Surgery
Date received: 2022-07-28
Decision date: 2022-09-23
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.