Device Classification Name |
Laser, Ophthalmic
|
510(k) Number |
K021538 |
Device Name |
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR |
Applicant |
LIGHTMED CORP. |
NO.1-1, LANE1,PAO-AN ST. SEC.3 |
SHULIN CITY,
TW
238
|
|
Applicant Contact |
IRENE LIN |
Correspondent |
LIGHTMED CORP. |
NO.1-1, LANE1,PAO-AN ST. SEC.3 |
SHULIN CITY,
TW
238
|
|
Correspondent Contact |
IRENE LIN |
Regulation Number | 886.4390
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/10/2002 |
Decision Date | 08/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|