Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K062719 |
Device Name |
GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES |
Applicant |
LASERSCOPE |
3070 ORCHARD DR. |
SAN JOSE,
CA
95134 -2011
|
|
Applicant Contact |
PAUL HARDIMAN |
Correspondent |
LASERSCOPE |
3070 ORCHARD DR. |
SAN JOSE,
CA
95134 -2011
|
|
Correspondent Contact |
PAUL HARDIMAN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/12/2006 |
Decision Date | 12/01/2006 |
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
|
Recalls |
CDRH Recalls
|