Device Classification Name |
ophthalmic femtosecond laser
|
510(k) Number |
K141079 |
Device Name |
OPTIMEDICA CATALYS PRECISION LASER SYSTEM |
Applicant |
OPTIMEDICA CORPORATION |
1310 MOFFETT PARK DRIVE |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
STEVE JWANOUSKOS |
Correspondent |
Johnson & Johnson Surgical Vision, Inc. |
31 Technology Drive, Suite 200 |
Irvine,
CA
92618
|
|
Correspondent Contact |
STEVE JWANOUSKOS |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 04/25/2014 |
Decision Date | 09/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|