510(k) K241398

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

K241398 is an FDA 510(k) premarket notification submitted by Tianjin Mastervision Technology Co., Ltd. for the device "SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses". The FDA issued a decision of Substantially Equivalent on October 22, 2024. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916.

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