C-65 Daily Contact Lens Cleaner
by Advanced Medical Optics, Inc.
PMA P790024
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP790024 | Date29 Nov 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Lc-65 Daily Contact Lens Cleaner
- 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
- S007
Overview
AI-generated summary, 18 Sep 2026
This device is a Contact Lens Cleaner, classified under accessories for soft contact lenses. It is designed to clean and maintain daily-wear soft contact lenses by removing debris, proteins, and deposits to ensure proper hygiene and lens clarity.
The C-65 Daily Contact Lens Cleaner is intended for home use and is supplied as a single-use solution. It is regulated under FDA PMA (Premarket Approval) as a Class II device (product code LPN) and complies with regulation 886.5928. The solution is non-sterile and must be stored in a cool, dry place away from direct sunlight.
Other devices from Advanced Medical Optics, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the C-65 Daily Contact Lens Cleaner intended for and how does it work?
The C-65 Daily Contact Lens Cleaner is designed specifically for home use to clean and maintain daily-wear soft contact lenses. It removes debris, proteins, and deposits to ensure proper hygiene and lens clarity, helping to keep lenses clean and comfortable for wearers.
Is the C-65 Daily Contact Lens Cleaner single-use or reusable, and what are its storage requirements?
The C-65 Daily Contact Lens Cleaner is supplied as a single-use solution, meaning each bottle is intended for one-time use. Since it is non-sterile, it must be stored in a cool, dry place away from direct sunlight to maintain its effectiveness and safety.
What regulatory pathway does the C-65 Daily Contact Lens Cleaner follow, and what class is it assigned?
The C-65 Daily Contact Lens Cleaner is regulated under the FDA’s Premarket Approval (PMA) pathway as a Class II device, classified under product code LPN (Accessories for Soft Contact Lenses). This classification aligns with its role as an accessory for maintaining soft contact lens hygiene.
Are there multiple versions or sizes of the C-65 Daily Contact Lens Cleaner, and how would I identify the correct one?
The C-65 Daily Contact Lens Cleaner is listed under multiple FEI (Final Establishment Identification) numbers, indicating it may have been distributed under various lot or batch identifiers, but there is no indication of differing sizes or models in the provided data. The trade name remains consistent as LC-65, so verifying the label or packaging ensures you have the correct product.