FDA 510(k)

Samfilcon B Custom Contact Lens

K-Number: K230954 · 2023-11-17

Decision Date2023-11-17

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Samfilcon B Custom Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Bausch + Lomb, Incorporated. It received FDA 510(k) clearance on 2023-11-17 under 510(k) number K230954. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Samfilcon B Custom Contact Lens?

Samfilcon B Custom Contact Lens is a medical device that received FDA 510(k) clearance on 2023-11-17. The listed applicant is Bausch + Lomb, Incorporated. The 510(k) number is K230954.

When did Samfilcon B Custom Contact Lens receive FDA 510(k) clearance?

Samfilcon B Custom Contact Lens received FDA 510(k) clearance on 2023-11-17, under 510(k) number K230954.

Who is the listed applicant for Samfilcon B Custom Contact Lens?

The FDA 510(k) record lists Bausch + Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Samfilcon B Custom Contact Lens?

The FDA product code for Samfilcon B Custom Contact Lens is LPL.

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Other records listing Bausch + Lomb, Incorporated as applicant

PMA P240005Lens, multifocal intraocular PMA P910056intraocular lens PMA P910071Fluid, intraocular PMA P860022Lens, contact (rigid gas permeable), extended wear PMA P010062Lens, contact, orthokeratology, overnight PMA N16895Lenses, soft contact, extended wear

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Related Devices (Code: LPL)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.