Class Class II

SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses (K241398)

K241398 2024-10-22 Traditional
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Description

SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses by Tianjin Mastervision Technology Co., Ltd., an FDA 510(k) cleared ophthalmic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241398
Clearance Date2024-10-22
Clearance TypeTraditional
Product CodeHQD
Regulation Number886.5916

Categories

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Predicate lineage for K241398

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses (K241398) cites 3 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact L...Acuity Polymers, Inc.2024
K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.2021
K201194Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.2020

Trace the full predicate network for K241398

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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