Clearance Summary
Neo Sculptor (OF-NEO001) received FDA 510(k) clearance under submission number K242186, sponsored by Ofan Intelligent Technology (Guangzhou) Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2024-09-17.
- Submission: K242186
- Applicant / Sponsor: Ofan Intelligent Technology (Guangzhou) Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2024-09-17
Classification & Regulation
This clearance is catalogued under FDA product code NGX and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.