Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K885164 |
Device Name |
LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM |
Applicant |
CHIRON VISION CORP. |
9342 JERONIMO RD. |
IRVINE,
CA
92618 -1903
|
|
Applicant Contact |
SUSAN GAMBLE |
Correspondent |
CHIRON VISION CORP. |
9342 JERONIMO RD. |
IRVINE,
CA
92618 -1903
|
|
Correspondent Contact |
SUSAN GAMBLE |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 12/13/1988 |
Decision Date | 01/10/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|