Vivace Electrosurgical System
Catalogue number VIVACE, listed by ShenB Co Ltd, South Korea, under Skin Resurfacing Rf Applicator. 2 manufacturers in China are registered for this product code.
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 | ShenB Co Ltd, South Korea |
|---|---|
| FDA product code | OUH |
| Device type | Skin Resurfacing Rf Applicator |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Manufacturer |
| 510(k) | K150409 |
| Record published | 2019-10-11 |
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 |
|---|---|---|
| VIVACE | 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 |
| Fraxis Duo Needle H/P | Ilooda Co,., Ltd. | 1 |
| Quadessy Deeplus hand piece | Classys Inc | 1 |
Showing 12 of 24. All products under Skin Resurfacing Rf Applicator
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Aesthetics Biomedical Inc. | 510(k) number | 2020-03-13 | Class II | No Marketing Application | A high frequency output (2 MHz) has not been cleared for distribution in the U.S. | 623 units | 2021-09-01 |
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.