Acuvue 2 Colours Brand (Etafilcon A) Soft Contact Lens with UV Blocker
by Johnson & Johnson Vision Care, Inc.
510(k) K024177
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK024177 | Date22 Jan 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker
- 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
Overview
AI-generated summary, 20 Sep 2026
This device is a Soft (Hydrophilic) Contact Lens designed for daily wear, classified under the FDA’s Lenses, Soft Contact, Daily Wear category. It incorporates a visibility tint to enhance or alter eye color while providing refractive correction. The lens material, etafilcon A, is formulated to offer comfort and clarity for extended use, with integrated UV protection to shield the eyes from harmful ultraviolet radiation.
The lenses are supplied as single-use, disposable items intended for daily wear only. They are regulated under FDA 510(k) clearance (K024177) as substantially equivalent to predicate devices, adhering to 21 CFR 886.5925 standards. Available in multiple registration numbers (e.g., 3015533540, 3012546757), they require proper fitting by an eye care professional and storage in a clean, dry environment as per manufacturer guidelines.
Other devices from Johnson & Johnson Vision Care, Inc.
Questions
AI-generated answers, 20 Sep 2026
Are these contact lenses designed for extended wear, or are they only meant for daily use?
These lenses are specifically formulated for daily wear only, not extended wear. The product description explicitly states they are intended as single-use, disposable items for daily use, providing refractive correction and color enhancement while ensuring comfort and clarity during the day.
Do these lenses come with built-in UV protection, and if so, how does that work?
Yes, these lenses include an integrated UV blocker to shield the eyes from harmful ultraviolet radiation. The visibility tint not only enhances or alters eye color but also contributes to this protective feature, ensuring added safety during outdoor exposure.
How should these lenses be stored, and are they single-use or reusable?
These lenses are single-use and disposable, meaning each lens is intended for one day of wear only. The manufacturer recommends storing them in a clean, dry environment before use, though they are not designed for reuse or long-term storage.
What material are these lenses made from, and how does that affect comfort and clarity?
The lenses are made from etafilcon A, a hydrophilic material known for providing comfort and clarity. This material is designed to maintain moisture and flexibility, ensuring a stable fit and clear vision throughout the day.
What regulatory pathway was followed for this product, and what does that mean for its safety and equivalence?
This product received FDA 510(k) clearance (K024177) under the classification *Lenses, Soft Contact, Daily Wear*, with a decision of *Substantially Equivalent* to predicate devices. This means the FDA determined it meets the same performance standards as previously approved daily-wear soft contact lenses, ensuring its safety and effectiveness for the intended use.