Neo Sculptor (OF-NEO001)— 510(k) K242186

Name: FDA 510(k) clearance K242186
Creator: U.S. Food and Drug Administration
Published: 2024-09-17

Substantially Equivalent

Ofan Intelligent Technology (Guangzhou) Co. , Ltd.

FDA 510(k) clearance K242186 for Neo Sculptor (OF-NEO001), Substantially Equivalent on 2024-09-17. Applicant: Ofan Intelligent Technology (Guangzhou) Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Ofan Intelligent Technology (Guangzhou) Co. , Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2024-07-25
Decision date: 2024-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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