Data / Medical devices / China / Ofan Intelligent Technology (guangzhou) Co. Ltd.
Ofan Intelligent Technology (guangzhou) Co. Ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 1 510(k) clearance
Ofan Intelligent Technology (guangzhou) Co. Ltd. is registered with the FDA (registration 3033850524) in Guangzhou Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 17, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3033850524
- Address
- Floor 4rd Building F, Jintai Creation Park Jiahuo Helong No. 1 Rd. NO 6, Baiyun District, Guangzhou Guangdong, China, 510000
- Owner or operator
- OFAN Intelligent Technology (Guangzhou) Co. Ltd. (10085922)
- Roles
- Manufacturer
- First device listed
- October 30, 2024
- Registered through
- 2026
- Brand names listed
- High frequency devices, LED devices, hair care devices, PEMF devices, Lower frequency machine, plasma machine, hydra facial machine, skin analyzer machine, High-Intensity Focused Ultrasound(HIFU), Neo sculptor, Model: OF-NEO001, RF ems machine, ultrasound cavitation machine, shockwave therapy, cryolipolysis machine, microneedling RF
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 17, 2024 | K242186 | Neo Sculptor (OF-NEO001) | NGX | Substantially Equivalent | Ofan Intelligent Technology (Guangzhou) Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Brush, Dermabrasion, Powered
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
Updated September 17, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.