Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K100746 |
Device Name |
FIBER ONE |
Applicant |
AMERICAN MEDICAL SYSTEMS |
155-A MOFFETT PARK DRIVE |
SUITE 210 |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
DARLENE CROCKETT-BILLIG |
Correspondent |
AMERICAN MEDICAL SYSTEMS |
155-A MOFFETT PARK DRIVE |
SUITE 210 |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
DARLENE CROCKETT-BILLIG |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/16/2010 |
Decision Date | 06/11/2010 |
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
|