Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K972575 |
Device Name |
800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES |
Applicant |
LASERSCOPE |
3052 ORCHARD DR. |
SAN JOSE,
CA
95134 -2011
|
|
Applicant Contact |
LISA MCGRATH |
Correspondent |
LASERSCOPE |
3052 ORCHARD DR. |
SAN JOSE,
CA
95134 -2011
|
|
Correspondent Contact |
LISA MCGRATH |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 07/10/1997 |
Decision Date | 07/17/1998 |
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
|