Device Classification Name |
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device |
510(K) Number |
K182523 |
Device Name |
Lenses, Soft Contact, Daily Wear |
Applicant |
Largan Medical Co., Ltd.
2F., No. 14, 23rd Rd., Taichung Industrial Park,
Nantun Dist.,
Taichung 40850 TW
Other 510(k) Applications for this Company
|
Contact |
Amy Tien
Other 510(k) Applications for this Contact |
Regulation Number |
886.5925
More FDA Info for this Regulation Number |
Classification Product Code |
LPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/13/2018 |
Decision Date |
11/01/2018 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OP - Ophthalmic |
Review Advisory Committee |
OP - Ophthalmic |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|