Complete Brand Multi-Purpose Solution, Complete Brand Lubricating and Rewetting Drops
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K981168 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)
This device is a sterile, isotonic, buffered, aqueous contact lens care solution designed for the cleaning, disinfecting, lubricating, and rewetting of soft contact lenses. It contains purified water, sodium chloride, hydroxypropyl methylcellulose (as a lubricant), polyhexamethylene biguanide (preservative), Poloxamer 237 (surfactant), phosphate buffer, and edetate disodium (chelating agent). The formulation supports daily maintenance and comfort for extended wear lenses.
The solution is supplied as a sterile, single-use or multi-use formulation (depending on packaging) and is intended for use in ophthalmic settings. It adheres to FDA 510(k) clearance (K981168) under product code LPN (Accessories, Soft Lens Products) and is classified as a Class II medical device under special controls. Storage instructions and sterility are specified in the packaging, ensuring compatibility with soft contact lens care routines.
Frequently asked questions
What is the Complete Brand Multi-Purpose Solution designed for?
This solution is specifically formulated for the cleaning, disinfecting, lubricating, and rewetting of soft contact lenses. Its isotonic, buffered, and aqueous composition ensures compatibility with extended wear lenses, providing daily maintenance and enhanced comfort for users.
How is the Complete Brand Multi-Purpose Solution supplied, and what does this mean for sterility?
The solution is supplied in sterile packaging, available in both single-use and multi-use formulations depending on the packaging. Sterility is maintained throughout its shelf life, ensuring safe use in ophthalmic settings without compromising the integrity of the contact lenses.
Is this solution suitable for daily use with extended wear lenses?
Yes, the Complete Brand Multi-Purpose Solution is designed to support daily maintenance and comfort for extended wear lenses. Its formulation includes lubricants like hydroxypropyl methylcellulose and a preservative (polyhexamethylene biguanide) to maintain lens hygiene and moisture balance over prolonged wear.
What key ingredients are included in this solution, and why are they important?
The solution contains purified water, sodium chloride, hydroxypropyl methylcellulose (a lubricant), polyhexamethylene biguanide (a preservative), Poloxamer 237 (a surfactant), phosphate buffer, and edetate disodium (a chelating agent). These ingredients work together to ensure proper lens cleaning, disinfection, and rewetting while maintaining isotonicity and pH balance for eye safety.
How should the Complete Brand Multi-Purpose Solution be stored, and what are the regulatory considerations?
Storage instructions are detailed on the packaging to preserve sterility and efficacy. The solution adheres to FDA 510(k) clearance (K981168) under product code LPN, classifying it as a Class II medical device with special controls. Always follow the manufacturer’s guidelines to ensure compliance with regulatory requirements and optimal performance.
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: Complete Brand Multi-purpose Solution, Complete Brand Lubricating and ..., Complete Brand Multi-purpose Solution, Complete Brand Lubricating And ..., K981168 FDA 510 (k) - COMPLETE BRAND MULTI-PURPOSE SOLUTION
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K981168 | Class II | Active |
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Manufacturer
- Manufacturer
- Allergan, Inc.
Sources (1)
- FDA 510(k) K981168 24 fields · synced Oct 1, 2026