In a Wink Cleaning Solution
PMA P870005
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP870005 | Date28 Dec 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Accessories, soft lens products
- PMA Number
- FDA Product Code
- LPN
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5928
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S001 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The In a Wink Cleaning Solution is a cleaning solution for soft contact lenses, designed to remove deposits, disinfect, and maintain lens hygiene. Classified under Accessories, Soft Lens Products, it adheres to ophthalmic standards for lens care and maintenance.
This solution is supplied as a sterile, single-use or multi-use (depending on formulation) liquid for manual cleaning of soft contact lenses. It is intended for use in ophthalmic settings, including home and clinical environments, and complies with FDA Premarket Approval (PMA) under PMA Number P870005. Storage instructions and regulatory compliance are detailed in the accompanying labeling.
Other devices from Ciba-Geigy Corp.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the In a Wink Cleaning Solution, and how does it differ from regular contact lens solutions?
The In a Wink Cleaning Solution is specifically designed to remove deposits, disinfect, and maintain hygiene for soft contact lenses. Unlike basic saline solutions, it combines cleaning, disinfection, and maintenance in one step, making it suitable for both home and clinical use. It adheres to ophthalmic standards for lens care, ensuring thorough cleaning to prevent buildup and maintain lens clarity.
Is the In a Wink Cleaning Solution sterile, and how should it be stored?
Yes, the In a Wink Cleaning Solution is supplied as a sterile liquid. Storage instructions are detailed on the labeling, but generally, it should be kept in a cool, dry place away from direct sunlight. Proper storage ensures the solution remains effective for cleaning and disinfecting soft contact lenses.
Can this cleaning solution be used for both single-use and multi-use applications, or is it limited to one?
The In a Wink Cleaning Solution is available in formulations that can be used for either single-use or multi-use applications, depending on the specific variant. The labeling will specify which formulation is intended for single-use (e.g., disposable) and which is designed for reuse over multiple lens cleanings. Always follow the instructions provided to ensure proper use.
What regulatory pathway was followed for the approval of the In a Wink Cleaning Solution, and what does this mean for users?
The In a Wink Cleaning Solution received FDA Premarket Approval (PMA) under PMA Number P870005, which means it underwent rigorous review by the FDA to ensure safety, effectiveness, and compliance with ophthalmic standards. This approval indicates that the solution meets regulatory requirements for cleaning, disinfecting, and maintaining soft contact lenses in both home and clinical settings.