Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K120870 |
Device Name |
GREENLIGHT MOXY FIBER OPTIC |
Applicant |
AMERICAN MEDICAL SYSTEMS |
3070 ORCHARD DRIVE |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
DOREEN NAKAMURA |
Correspondent |
AMERICAN MEDICAL SYSTEMS |
3070 ORCHARD DRIVE |
SAN JOSE,
CA
95134
|
|
Correspondent Contact |
DOREEN NAKAMURA |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/22/2012 |
Decision Date | 06/15/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|