Device Classification Name |
Laser, Ophthalmic
|
510(k) Number |
K190448 |
Device Name |
LightLas Pattern Scanning System - TruScan Pro |
Applicant |
Light-Med(USA), INC. |
1130 Calle Cordillera |
San Clemente,
CA
92673
|
|
Applicant Contact |
Hedy Chiang |
Correspondent |
Light-Med(USA), INC. |
1130 Calle Cordillera |
San Clemente,
CA
92673
|
|
Correspondent Contact |
Hedy Chiang |
Regulation Number | 886.4390
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/25/2019 |
Decision Date | 05/24/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|