Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K862514 |
Device Name |
OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO |
Applicant |
LASERSCOPE |
3350 SCOTT BLVD., BLDG.30 |
SANTA CLARA,
CA
95051
|
|
Applicant Contact |
RICHARD P RUDY |
Correspondent |
LASERSCOPE |
3350 SCOTT BLVD., BLDG.30 |
SANTA CLARA,
CA
95051
|
|
Correspondent Contact |
RICHARD P RUDY |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 07/01/1986 |
Decision Date | 02/04/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|