Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K080530 |
Device Name |
MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE |
Applicant |
CUTERA, INC. |
3240 BAYSHORE BLVD |
BRISBANE,
CA
94005
|
|
Applicant Contact |
KATHY MAYNOR |
Correspondent |
CUTERA, INC. |
3240 BAYSHORE BLVD |
BRISBANE,
CA
94005
|
|
Correspondent Contact |
KATHY MAYNOR |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/26/2008 |
Decision Date | 08/15/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|