Ofan Intelligent Technology (Guangzhou) Co., Ltd.
Registered establishment in Guangzhou, Guangdong, China. 2 device types, 1 clearance.
Ofan Intelligent Technology (Guangzhou) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Brush, Dermabrasion, Powered, Stimulator, Muscle, Powered, For Muscle Conditioning. Its earliest product listing with the FDA dates from 2024.
2device types registered with the FDA
1510(k) clearance
Registration
| Registered name | OFAN INTELLIGENT TECHNOLOGY (GUANGZHOU) CO. LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3033850524 |
| FEI number | 3033850524 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 奥方智能科技（广州）有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | Floor 4rd Building F, Jintai Creation Park Jiahuo Helong No. 1 Rd. NO 6, Baiyun District |
| Postal code | 510000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | Class 1 | Lower frequency machine, plasma machine, hydra facial machine, skin analyzer machine, High-Intensity Focused Ultrasound(HIFU), RF ems machine, ultrasound cavitation machine, shockwave therapy, cryolipolysis machine, microneedling RF, High frequency devices, LED devices, hair care devices, PEMF devices | 2025 | 65 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | Class 2 | Neo sculptor, Model: OF-NEO001 | 2024 | 66 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242186 | 2024-09-17 | NGX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Employees | 100 |
| Factory area | 3500 m² |
| Main products | EMS sculpting, Plasma beauty devices, BBL slimming, HIFU, Cryolipolysis, RF machines, Hair therapy |
| Certifications | ISO13485, FDA |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.