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ACUVUE OASYS (senofilcon A) with Photochromic Additive

by Johnson & Johnson Vision Care, Inc. 510(k)

Active United States

510(k) K180299

Overview

This device is a Soft (Hydrophilic) Contact Lens, classified under FDA regulation 21 CFR 886.5925. It is designed for daily wear to correct refractive ametropia, including myopia, hyperopia, and presbyopia in phakic eyes. The lens incorporates a photochromic additive in senofilcon A material, providing adaptive tinting properties.

The ACUVUE OASYS (senofilcon A) with Photochromic Additive is supplied as a single-use, non-sterile product intended for ophthalmic use. It is regulated under FDA Class II and received FDA 510K clearance as substantially equivalent. Multiple FEI numbers (e.g., 3015533540) correspond to its registration, and it is distributed by Johnson & Johnson Vision Care, Inc. in Jacksonville, FL.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK180299 Date10 Apr 2018ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What types of vision issues can the ACUVUE OASYS (senofilcon A) with Photochromic Additive correct, and how does the photochromic feature benefit the wearer?

    This lens is designed to correct refractive ametropia, including myopia (nearsightedness), hyperopia (farsightedness), and presbyopia (age-related difficulty focusing on close objects) in phakic eyes (eyes with a natural lens). The photochromic additive in the senofilcon A material provides adaptive tinting, meaning the lens darkens automatically in bright sunlight and lightens in lower light conditions, offering convenience for outdoor activities without needing to switch lenses.

  • Is this lens intended for daily wear only, or can it be worn overnight? If not, what are the recommended wearing guidelines?

    The ACUVUE OASYS (senofilcon A) with Photochromic Additive is explicitly designed for daily wear only, meaning it is not approved for continuous or extended wear, including overnight use. The manufacturer’s instructions should be followed for proper wearing schedules to ensure safety and comfort.

  • How is this lens supplied, and is it sterile? Does it require any special handling before use?

    The ACUVUE OASYS (senofilcon A) with Photochromic Additive is supplied as a single-use, non-sterile product. Since it is not sterile, it should be handled with clean hands and placed directly on the eye after removal from the packaging. Proper hygiene practices, such as washing hands before handling, are recommended to minimize infection risk.

  • What regulatory pathway was followed for FDA clearance, and how does this affect its classification?

    The device received FDA 510K clearance under the Traditional 510(k) pathway, demonstrating it is substantially equivalent to a legally marketed predicate device. It is classified under FDA Class II, which means it has special controls to ensure its safety and effectiveness, but it does not require pre-market approval (PMA). The clearance was granted by the Ophthalmic Devices Panel (OP) in 2018.