| Device Classification Name |
powered light based non-laser surgical instrument with thermal effect
|
|---|
| 510(K) Number |
K121515 |
|---|
| Model |
ISOLAZ 2 CONSOLE, CART, HANDPIECE AND TIPS
|
| Device Name |
ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM |
|---|
| Applicant |
| SOLTA MEDICAL, INC. |
| 25881 industrial blvd |
|
hayward,
CA
94545
|
|
| Contact |
kristine foss |
| Regulation Number | 878.4810
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 05/22/2012 |
|---|
| Decision Date | 06/05/2012 |
|---|
| 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
|
|---|
