Class Class II

Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism (K240918)

K240918 2024-10-25 Traditional
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Description

Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism by Bruno Vision Care, LLC, an FDA 510(k) cleared ophthalmic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK240918
Clearance Date2024-10-25
Clearance TypeTraditional
Product CodeLPL
Regulation Number886.5925

Categories

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Predicate lineage for K240918

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. Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism (K240918) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K090806SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC...Safilens, S.R.L.2009
K051900ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIT...Johnson & Johnson Vision Care, Inc.2005

Trace the full predicate network for K240918

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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