VelaShape II System
Vela Shape II System 100V, Packaged
3manufacturers in China registered for this device type
2catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Syneron Medical, Ltd., Israel |
|---|---|
| FDA product code | NUV |
| Device type | Massager, Vacuum, Light Induced Heating |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| 510(k) | K122579 |
| Record published | 2016-09-25 |
| Record revised | 2025-06-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Distribution end date | 2023-10-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG70331R | Withdrawn | |
| FG70321R | Withdrawn |
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 |
| 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 |
| Accent system | Alma Lasers Ltd. | 1 |
Showing 12 of 51. All products under Massager, Vacuum, Light Induced Heating
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122579 | 2012-09-13 |
| K071872 | 2007-08-22 |
| K070092 | 2007-07-27 |
| K050397 | 2005-06-09 |
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.