Define System
The DEFINE System is designed to deliver non-thermal RF energy to the skin and subdermal fat. .
3manufacturers in China registered for this device type
1catalogue number
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 | Inmode M.D Ltd |
|---|---|
| FDA product code | NUV |
| Device type | Massager, Vacuum, Light Induced Heating |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| 510(k) | K191855 |
| Record published | 2025-01-07 |
| Record revised | 2025-05-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 65 °C; Storage environment humidity 0 to 80 % RH; Storage environment atmospheric pressure 50 to 110 KiloPascal; Handling environment temperature 15 to 35 °C; Handling environment humidity 30 to 80 % RH; Handling environment atmospheric pressure 90 to 110 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AG612444A | 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
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.