| Device Classification Name |
powered laser surgical instrument
|
|---|
| 510(K) Number |
K121127 |
|---|
| Device Name |
SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS |
|---|
| Applicant |
| CYNOSURE, INC. |
| 5 carlisle road |
|
westford,
MA
01886
|
|
| Contact |
irina kulinets |
| Regulation Number | 878.4810
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 04/13/2012 |
|---|
| Decision Date | 05/13/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
General & Plastic Surgery
|
|---|
| Review Advisory Committee |
General & Plastic Surgery
|
|---|
| summary |
summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
