Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K911830 |
Device Name |
LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER |
Applicant |
LASERSCOPE |
C/O CHARLES L. ROSE & CO., INC |
1963 ROCK STREET, SUITE #17 |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
CHARLES L ROSE |
Correspondent |
LASERSCOPE |
C/O CHARLES L. ROSE & CO., INC |
1963 ROCK STREET, SUITE #17 |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
CHARLES L ROSE |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 04/24/1991 |
Decision Date | 08/14/1991 |
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
|