Neo Sculptor (OF-NEO001)
K-Number: K242186 · 2024-09-17
Decision Date2024-09-17
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Neo Sculptor (OF-NEO001) is a medical device manufactured by Ofan Intelligent Technology (Guangzhou) Co. , Ltd.. It received FDA 510(k) clearance on 2024-09-17 under approval number K242186. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Neo Sculptor (OF-NEO001)?
Neo Sculptor (OF-NEO001) is a medical device that received FDA 510(k) clearance on 2024-09-17. It is manufactured by Ofan Intelligent Technology (Guangzhou) Co. , Ltd.. The 510(k) number is K242186.
When was Neo Sculptor (OF-NEO001) approved by the FDA?
Neo Sculptor (OF-NEO001) received FDA 510(k) clearance on 2024-09-17, under approval number K242186.
What company makes Neo Sculptor (OF-NEO001)?
Neo Sculptor (OF-NEO001) is manufactured by Ofan Intelligent Technology (Guangzhou) Co. , Ltd..
What is the FDA product code for Neo Sculptor (OF-NEO001)?
The FDA product code for Neo Sculptor (OF-NEO001) is NGX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.