Pellefirm Handpiece
Pellefirm Vari-PAK USA 2 HP & 2 Heads
13manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (10), Beijing (2), Henan (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Shen Zhen HanShine Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Guangdong Fuqiang Beauty Equipment Co., Limited | Qingyuan | Guangdong | Manufacturer | 13 |
| Shenzhen Rainbow Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 12 |
| Shenzhen Margotan Tech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Zhengzhou PZ Laser Slim Technology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 6 |
| Shenzhen Leaflife Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 5 |
Showing 12 of 13. All 13 manufacturers in China registered for Massager, Vacuum, Radio Frequency Induced Heat
Record
| Listed by | Cynosure, LLC, United States |
|---|---|
| FDA product code | PBX |
| Device type | Massager, Vacuum, Radio Frequency Induced Heat |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K132949 |
| Record published | 2016-09-21 |
| Record revised | 2023-04-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| P325PFHPU | 3 | In distribution | |
| P330PFHPU | 3 | In distribution | |
| P3PFVP-WMHU | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Human Tecar | Unibell SRL | 32 |
| Supercharge Hydra Fascia Electrodes | Unibell SRL | 9 |
| Capenergy | Capenergy Medical SL | 5 |
| Zionic Aesthetic | Termosalud SL | 4 |
| Winback | Winback GO East Co Ltd | 3 |
| Emface controller | Btl Industries, Ltd. | 2 |
| Venus Legacy | Venus Concept Ltd. | 2 |
| Venus Legacy kit | Venus Concept Ltd. | 2 |
| OptiPLUS | Bios | 2 |
| Nuera Tight | Bios | 2 |
| Venus Legacy (120V) | Venus Concept Ltd. | 1 |
| Indiba Deep Care – Elite NS | Indiba | 1 |
Showing 12 of 150. All products under Massager, Vacuum, Radio Frequency Induced Heat
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200241 | 2020-03-25 |
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.