Device Classification Name |
powered laser surgical instrument |
|||
---|---|---|---|---|
510(k) Number | K021946 | |||
Device Name | CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM | |||
Original Applicant |
|
|||
Original Contact | glen goff | |||
Regulation Number | 878.4810 | |||
Classification Product Code |
|
|||
Date Received | 06/13/2002 | |||
Decision Date | 09/11/2002 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
General & Plastic Surgery |
|||
510k Review Panel |
General & Plastic Surgery |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |