Confees+ Contact Lens Holder
510(k) K897084
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK897084 | Date28 Feb 1990 | 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- Withdrawn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
- Full name
- Confees(R)+ Contact Lens Holder
- 510(k) Number
- FDA Product Code
- LRX
- 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 Confees+ Contact Lens Holder is a Case, Contact Lens designed to store and protect soft (hydrophilic) contact lenses. It provides a dedicated, enclosed space to maintain lens hygiene and integrity between use.
This device is intended for single-use or reusable storage of contact lenses, supplied sterile or non-sterile as specified by the manufacturer. It is classified as a Class II medical device under FDA regulation 886.5928 and holds an FDA 510(k) clearance (K897084) with a product code of LRX. Storage conditions and reuse instructions are detailed in the manufacturer’s instructions.
Other devices from Magnivision, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of contact lenses is the Confees+ Contact Lens Holder designed to store and protect?
The Confees+ Contact Lens Holder is specifically designed for storing and protecting soft (hydrophilic) contact lenses. It provides an enclosed space to maintain lens hygiene and integrity between uses, ensuring compatibility with this lens type.
Is the Confees+ Contact Lens Holder intended for single-use or reusable storage, and how should I determine which version I need?
The Confees+ Contact Lens Holder can be used for both single-use and reusable storage, depending on the version purchased. The manufacturer specifies whether each unit is sterile or non-sterile, so check the packaging or instructions to confirm which version aligns with your needs—sterile for one-time use or non-sterile for reuse.
How should I store the Confees+ Contact Lens Holder to maintain its effectiveness?
Storage conditions are outlined in the manufacturer’s instructions, but generally, the holder should be kept in a clean, dry environment to prevent contamination. Avoid exposure to extreme temperatures or moisture, as this could compromise its integrity or the lenses it stores. Always follow the provided guidelines for optimal preservation.
Are there different sizes or models of the Confees+ Contact Lens Holder, and if so, how do I identify which one is right for me?
The Confees+ Contact Lens Holder is listed under multiple registration numbers, but the specific sizes or models aren’t detailed in the provided data. However, since it’s designed for soft contact lenses, compatibility depends on the lens brand and type rather than the holder’s size. Verify the manufacturer’s instructions or consult a healthcare provider to ensure the correct fit for your lenses.