Painless IPL System - KDT750— 510(k) K220214

Name: FDA 510(k) clearance K220214
Creator: U.S. Food and Drug Administration
Published: 2023-02-18

Substantially Equivalent

Shanghai Omni Laser Skinology Co., Ltd.

FDA 510(k) clearance K220214 for Painless IPL System - KDT750, Substantially Equivalent on 2023-02-18. Applicant: Shanghai Omni Laser Skinology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Omni Laser Skinology Co., Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2022-01-26
Decision date: 2023-02-18
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.