Fraxis Duo Needle H/P
FRX 2.0 Needle H/P
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Syntech Laser Co., Ltd. | Beijing | Beijing | Contract manufacturer | 5 |
| Guangdong Fuqiang Beauty Equipment Co., Limited | Qingyuan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Ilooda Co,., Ltd., South Korea |
|---|---|
| FDA product code | OUH |
| Device type | Skin Resurfacing Rf Applicator |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| 510(k) | K160312 |
| Record published | 2016-12-16 |
| Record revised | 2023-04-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FRX 2.0 Needle H/P | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| INTRAgen Tip | Jeisys Medical Inc. | 2 |
| INTRAgen | Jeisys Medical Inc. | 1 |
| Max-M25C | Classys Inc | 1 |
| Virtue RF Microneedle Cartridge | ShenB Co Ltd | 1 |
| Quadessy Set Package | Classys Inc | 1 |
| Virtue RF | ShenB Co Ltd | 1 |
| Max-M25 | Classys Inc | 1 |
| EndyMed Intensif 10 pack tips package | Endymed Medical Ltd | 1 |
| Max-25C | Classys Inc | 1 |
| Max-25 | Classys Inc | 1 |
| Vivace Electrosurgical System | ShenB Co Ltd | 1 |
| Quadessy Deeplus hand piece | Classys Inc | 1 |
Showing 12 of 24. All products under Skin Resurfacing Rf Applicator
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.