FC Applicator
Catalogue number VRE2003, listed by Viora Ltd., Israel, under Massager, Vacuum, Light Induced Heating. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Beijing (2), Henan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Zhengzhou PZ Laser Slim Technology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 6 |
| Beijing Honkon Technologies Co., Ltd. | Beijing | Beijing | Manufacturer | 4 |
Record
| Listed by | Viora Ltd., Israel |
|---|---|
| FDA product code | NUV |
| Device type | Massager, Vacuum, Light Induced Heating |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K090221 |
| Record published | 2016-09-23 |
| Record revised | 2025-09-09 (version 5) |
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 |
|---|---|---|
| VRE2003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VelasmoothPro system | Syneron Medical, Ltd. | 4 |
| Vsmooth Applicator | Syneron Medical, Ltd. | 3 |
| Refurbished Velasmooth | Syneron Medical, Ltd. | 2 |
| Vcontour Applicator | Syneron Medical, Ltd. | 2 |
| VelaShape II system | Syneron Medical, Ltd. | 2 |
| Velasmooth system | Syneron Medical, Ltd. | 2 |
| Vela Shape II system | Syneron Medical, Ltd. | 2 |
| VelaShape system | Syneron Medical, Ltd. | 2 |
| T-Shape 2 | B&M SRL Marketing NEL Benessere | 1 |
| Accent Elite System 110V (Black) | Alma Lasers Ltd. | 1 |
| Repl. Cover,(White) LA-8Hr, Stacking | Syneron Medical, Ltd. | 1 |
| Accent Elite Uniform HP | Alma Lasers Ltd. | 1 |
Showing 12 of 51. All products under Massager, Vacuum, Light Induced Heating
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K090221 | 2009-07-01 |
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.