Refresh Contacts Lubricating and Rewetting Drops
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K992028 FDA 510(k)
- FDA Product Code
- LPN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.5928 FDA 510(k)
- Regulation Number
- 886.5928 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Refresh Contacts Lubricating and Rewetting Drops are classified as Accessories, Soft Lens Products under the FDA nomenclature. These sterile ophthalmic drops are designed to lubricate and rewet contact lenses, providing relief from dryness, irritation, and discomfort associated with lens wear. Formulated specifically for contact lens users, they help maintain lens comfort throughout extended use by restoring moisture and reducing friction.
Supplied as single-use sterile drops, this device is intended for ocular application only and is regulated under FDA 510(k) clearance (K992028) as an Abbreviated submission in the Ophthalmic advisory committee category. The product is packaged in 8 mL and 0.27 mL volumes, adhering to Device Class II standards. Storage and handling must comply with sterile ophthalmic product protocols to ensure efficacy and safety. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the device data.
Frequently asked questions
What is the primary purpose of Refresh Contacts Lubricating and Rewetting Drops?
These drops are specifically formulated to lubricate and rewet contact lenses, providing relief from dryness, irritation, and discomfort caused by extended lens wear. By restoring moisture and reducing friction, they help maintain lens comfort throughout the day.
How are Refresh Contacts Lubricating and Rewetting Drops supplied, and what does this mean for usage?
The product is supplied as single-use sterile drops, ensuring each application is free from contamination. This design minimizes the risk of introducing pathogens to the eye, making it ideal for repeated use throughout the day without compromising sterility.
Are these drops reusable, or are they intended for single-use only?
The drops are explicitly designed for single-use per application. While the packaging contains multiple doses (8 mL or 0.27 mL), each drop should be used once and discarded to maintain sterility and safety, as required for sterile ophthalmic products.
What storage and handling precautions should be taken for Refresh Contacts Lubricating and Rewetting Drops?
Since these are sterile ophthalmic drops, storage and handling must adhere to strict sterile protocols. The packaging should remain unopened until use, and after opening, the drops should be used promptly. Avoid contamination by keeping the dropper tip away from surfaces or hands, and store in a cool, dry place away from direct sunlight.
What sizes or volumes are available for Refresh Contacts Lubricating and Rewetting Drops?
The product is available in two volumes: an 8 mL bottle, suitable for extended use over multiple days, and a 0.27 mL single-dose vial, ideal for travel or on-the-go application. Both volumes maintain the same sterile, single-use formulation for each application.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Amazon.com : Refresh Contacts, Lubricant Eye Drops, Contact Lens ..., Refresh Drops Contacts - Walmart.com, Refresh Contacts Uses, Side Effects & Warnings - Drugs.com, Refresh Relieva for contacts Lubricant Eye Drops Artificial Tears ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K992028 | Class II | Active |
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Manufacturer
- Manufacturer
- Allergan, Inc.
Sources (1)
- FDA 510(k) K992028 24 fields · synced Oct 1, 2026