Contact Lens Case Round Glasses
510(k) K171163
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171163 | Date27 Jun 2017 | 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- Withdrawn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
- 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
This device is a Contact Lens Case designed for the storage and chemical disinfection of contact lenses. It features two adjoining wells with snap lids and silicone seals to maintain hygiene and prevent contamination during immersion in disinfecting solution.
The case is constructed from polycarbonate (PC), thermoplastic elastomer (TPE), and acrylonitrile butadiene styrene (ABS) plastics, with stainless steel hinges for durability. Supplied as a single-use or reusable item (as specified by the manufacturer), it is intended for home use by patients to store lenses in labeled compartments marked ‘L’ (left) and ‘R’ (right). It has received FDA 510(k) clearance under the Ophthalmic advisory committee and is classified as a Class II medical device (LRX).
Questions
AI-generated answers, 19 Sep 2026
Are these contact lens cases designed for single-use or can they be reused, and how does that affect their material construction?
These contact lens cases are available in both single-use and reusable versions, as specified by the manufacturer. The material construction—polycarbonate (PC), thermoplastic elastomer (TPE), acrylonitrile butadiene styrene (ABS), and stainless steel hinges—is designed to balance durability and hygiene. Reusable cases are built to withstand repeated use, while single-use cases prioritize disposable convenience to minimize contamination risks between patients.
How do the labeled compartments (‘L’ and ‘R’) in this contact lens case help users, and what materials ensure their hygiene?
The labeled ‘L’ (left) and ‘R’ (right) compartments in this case help users organize their lenses correctly, reducing the risk of mixing or misplacing them. The silicone seals around the snap lids create a tight barrier to maintain hygiene and prevent contamination during immersion in disinfecting solution, ensuring lenses stay protected and clean.
What materials are used in the construction of this contact lens case, and why might that matter for users?
This contact lens case is made from polycarbonate (PC), thermoplastic elastomer (TPE), acrylonitrile butadiene styrene (ABS), and stainless steel hinges. These materials combine durability with resistance to wear and tear, ensuring the case lasts through repeated use (if reusable) while maintaining structural integrity. The choice of materials also helps prevent bacterial growth and contamination, which is critical for maintaining lens hygiene.
Is this contact lens case intended for home use, and what features support that purpose?
Yes, this contact lens case is explicitly designed for home use by patients. Its two adjoining wells with snap lids and silicone seals are engineered to facilitate easy storage and chemical disinfection of lenses in a domestic setting. The labeled ‘L’ and ‘R’ compartments further simplify lens organization, making it user-friendly for daily maintenance.
What regulatory pathway was followed for this device, and what does that tell buyers about its classification?
This contact lens case received FDA 510(k) clearance under the Ophthalmic advisory committee, classified as a Class II medical device with the product code LRX. The clearance indicates it was determined to be substantially equivalent to a predicate device, meaning it meets established safety and effectiveness standards for contact lens storage and disinfection. Buyers can rely on this classification for assurance of regulatory scrutiny.