510(k) K241398

SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses by Tianjin Mastervision Technology Co., Ltd. — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2024
Date Received
May 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Other Material) - Daily
Device Class
Class II
Regulation Number
886.5916
Review Panel
OP
Submission Type