Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K103547 |
Device Name |
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM |
Applicant |
LIGHTMED CORP. |
NO.1-1, LANE1,PAO-AN ST. SEC.3 |
SHULIN CITY,
TW
238
|
|
Applicant Contact |
JOCELYN LIU |
Correspondent |
LIGHTMED CORP. |
NO.1-1, LANE1,PAO-AN ST. SEC.3 |
SHULIN CITY,
TW
238
|
|
Correspondent Contact |
JOCELYN LIU |
Regulation Number | 886.4390
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/02/2010 |
Decision Date | 11/03/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|