Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K092735 |
Device Name |
GREENLIGHT XPS LASER SYSTEM |
Applicant |
AMERICAN MEDICAL SYSTEMS, INC. |
155-A MOFFETT PARK DR. |
SUITE 210 |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
DARLENE-CROCKET BILLIG |
Correspondent |
AMERICAN MEDICAL SYSTEMS, INC. |
155-A MOFFETT PARK DR. |
SUITE 210 |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
DARLENE-CROCKET BILLIG |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/04/2009 |
Decision Date | 11/09/2009 |
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
|