Duraclean Daily Cleaner
510(k) K881987
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK881987 | Date9 Jun 1988 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- LPN
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5928
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Duraclean Daily Cleaner is a soft lens cleaning solution designed for daily maintenance of contact lenses. Classified under the nomenclature for Accessories, Soft Lens Products, this device is intended for cleaning and disinfecting soft contact lenses to ensure hygiene and comfort during wear.
Supplied as a sterile solution, the Duraclean Daily Cleaner is intended for single-use per lens cleaning cycle. It is regulated under FDA 510(k) clearance (K881987) with a classification of Class II, adhering to regulatory standards for ophthalmic accessories. The product is distributed under the product code LPN and is authorized for use in ophthalmic settings as specified in regulation 886.5928.
Other devices from Allergan Optical
Questions
AI-generated answers, 19 Sep 2026
What is the Duraclean Daily Cleaner primarily used for in clinical practice?
The Duraclean Daily Cleaner is designed specifically for cleaning and disinfecting soft contact lenses to maintain hygiene and ensure comfort during wear. It is intended to be used daily as part of routine lens maintenance in ophthalmic settings.
Is the Duraclean Daily Cleaner meant for single-use or repeated use in a cleaning cycle?
The Duraclean Daily Cleaner is supplied as a sterile solution intended for single-use per lens cleaning cycle. This ensures each cleaning process begins with a fresh, uncontaminated solution, reducing the risk of introducing bacteria or residue to the lenses.
How is the Duraclean Daily Cleaner regulated, and what does that mean for its use?
The Duraclean Daily Cleaner has received FDA 510(k) clearance (K881987) and is classified as a Class II device under the regulatory category for ophthalmic accessories, specifically soft lens products. This means it has undergone evaluation to demonstrate substantial equivalence to a predicate device and meets FDA standards for safety and effectiveness in cleaning and disinfecting soft contact lenses.
Are there different sizes or models of the Duraclean Daily Cleaner, and how would I identify them?
The Duraclean Daily Cleaner is listed under multiple registration numbers (e.g., 3010607087, 1610287, etc.) and FEI numbers, which may correspond to different packaging sizes or variants. However, the core product remains the same—sterile, single-use cleaning solution for soft contact lenses. For precise identification, refer to the specific lot or batch number on the packaging, as these numbers help trace the product’s regulatory compliance and batch details.
How should the Duraclean Daily Cleaner be stored, and does sterility need to be maintained?
While the exact storage instructions aren’t detailed in the provided data, the Duraclean Daily Cleaner is supplied as a sterile solution, so it should be stored in a clean, dry place away from direct sunlight or extreme temperatures to preserve its sterility and efficacy. Always follow the manufacturer’s instructions on the packaging for optimal storage conditions.