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FDA 510(k) Application Details - K211603
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K211603
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
Pegavision Corporation
2F-1, No. 5 Shing Yeh St
Taoyuan 33341 TW
Other 510(k) Applications for this Company
Contact
Estela Lin
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
05/24/2021
Decision Date
02/02/2022
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
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