Device Classification Name |
Laser, Ophthalmic
|
510(k) Number |
K050807 |
Device Name |
20G SMA LASER FIBER, MODEL LF100 |
Applicant |
OPHTHALMED LLC |
1308 MORNINGSIDE PARK DR. |
ALPHARETTA,
GA
30022
|
|
Applicant Contact |
JAY MANSOUR |
Correspondent |
OPHTHALMED LLC |
1308 MORNINGSIDE PARK DR. |
ALPHARETTA,
GA
30022
|
|
Correspondent Contact |
JAY MANSOUR |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 03/30/2005 |
Decision Date | 09/21/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|