Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K091064 |
Device Name |
NAVILAS LASER SYSTEM |
Applicant |
OD -OS GMBH |
733 BOLSANA DRIVE |
LAGUNA BEACH,
CA
92651
|
|
Applicant Contact |
Judy Gordon |
Correspondent |
OD -OS GMBH |
733 BOLSANA DRIVE |
LAGUNA BEACH,
CA
92651
|
|
Correspondent Contact |
Judy Gordon |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 04/14/2009 |
Decision Date | 10/27/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|