Mirari Cold Plasma System Array
The Mirari Cold Plasma System array is the treatment interface used with the Mirari radiofrequency generator to apply therapeutic heating. The system is intended to temporarily relieve pain…
The Mirari Cold Plasma System array is the treatment interface used with the Mirari radiofrequency generator to apply therapeutic heating. The system is intended to temporarily relieve pain and muscle spasms and increase local circulation by elevating tissue temperature.
The array contains interconnected metal rings and is placed inside a fleece pouch against the skin. Radiofrequency energy from the separate generator passes through the array, forming the system’s treatment interface.
System Use
The array is used as part of the prescription Mirari system with its generator and power supply. The fleece covering forms the patient-contact surface.
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 | General Vibronics, Inc., United States |
|---|---|
| FDA product code | PBX |
| Device type | Massager, Vacuum, Radio Frequency Induced Heat |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Manufacturer |
| 510(k) | K242553 |
| Record published | 2025-04-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GVPA-10BB | 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 |
| Pellefirm Handpiece | Cynosure, LLC | 3 |
| 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 |
Showing 12 of 150. All products under Massager, Vacuum, Radio Frequency Induced Heat
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242553 | 2024-11-21 |
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.