LA Repl. Cvr. (1hr) 10-Pk
LA Repl. Cvr. (1Hr) 10-Pk, VelaShape II
3manufacturers in China registered for this device type
1catalogue number
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 |
| Record published | 2016-09-26 |
| Record revised | 2025-06-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Distribution end date | 2023-06-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KT71745 | Withdrawn |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 |
| 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 |
|---|---|
| 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.