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FDA 510(k)

Neo Sculptor (OF-NEO001)

K-Number: K242186 · 2024-09-17

ApplicantOfan Intelligent Technology (Guangzhou) Co. , Ltd.
Decision Date2024-09-17
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Neo Sculptor (OF-NEO001) is the device name listed in this FDA 510(k) record. The listed applicant is Ofan Intelligent Technology (Guangzhou) Co. , Ltd.. It received FDA 510(k) clearance on 2024-09-17 under 510(k) 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. The listed applicant is Ofan Intelligent Technology (Guangzhou) Co. , Ltd.. The 510(k) number is K242186.

When did Neo Sculptor (OF-NEO001) receive FDA 510(k) clearance?

Neo Sculptor (OF-NEO001) received FDA 510(k) clearance on 2024-09-17, under 510(k) number K242186.

Who is the listed applicant for Neo Sculptor (OF-NEO001)?

The FDA 510(k) record lists Ofan Intelligent Technology (Guangzhou) Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neo Sculptor (OF-NEO001)?

The FDA product code for Neo Sculptor (OF-NEO001) is NGX.

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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