SLT II
The Cynosure SLT II workstation has a solid state Nd:YAG laser capable of emitting laser radiation in three wavelenghts and includes a wide range of different delivery system, handpieces,…
The Cynosure SLT II workstation has a solid state Nd:YAG laser capable of emitting laser radiation in three wavelenghts and includes a wide range of different delivery system, handpieces, fibers, cannulas and other accessories.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
Record
| Listed by | El.en. SPA |
|---|---|
| FDA product code | OYW |
| Device type | Laser, Cellulite Appearance |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| 510(k) | K091537 |
| Record published | 2016-09-13 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 5 to 50 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 10 to 30 °C; Handling environment humidity 20 to 80 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M094E1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cellulaze Handpiece, 2 Pack | Cynosure, LLC | 1 |
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.