GE Noryl 731-80089S Contact Lens Case
510(k) K873821
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873821 | Date24 Mar 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- Withdrawn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
- Full name
- GE Noryl 731-80089S
- 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 GE Noryl 731-80089S is a contact lens case, designed to store and protect single-use or reusable contact lenses. This device falls under the classification of a contact lens case, intended for ophthalmic use to maintain lens hygiene and integrity between wear.
This case is supplied as a reusable device, intended for use in domestic or clinical settings. It is not sterile upon packaging and must be cleaned and disinfected according to manufacturer guidelines. The device is classified as Class II under FDA regulations and holds an FDA 510(k) clearance (K873821) for substantial equivalence in ophthalmic applications. The product code LRX identifies it as a contact lens case within regulatory filings.
Other devices from Applied Laboratories, Inc.
Questions
AI-generated answers, 19 Sep 2026
Is this contact lens case designed for single-use or reusable contact lenses, and how should it be maintained?
The GE Noryl 731-80089S is a reusable contact lens case intended for both domestic and clinical use. Since it is not sterile upon packaging, it must be cleaned and disinfected according to the manufacturer’s guidelines to maintain hygiene and prevent contamination between uses. Proper maintenance ensures the case remains effective in protecting lens integrity.
What storage conditions should be followed for this contact lens case?
While the device data does not specify exact storage conditions, reusable contact lens cases like this one generally require clean, dry storage away from direct sunlight, extreme temperatures, and moisture to prevent bacterial growth or material degradation. Always follow the manufacturer’s instructions for optimal longevity.
How do I know this device is compliant with regulatory standards, and what does the FDA clearance mean?
The GE Noryl 731-80089S holds an FDA 510(k) clearance (K873821), confirming it is classified as Class II and deemed substantially equivalent to a legally marketed predicate device for ophthalmic use. This clearance indicates it meets FDA requirements for safety and effectiveness as a contact lens case, but it does not imply sterility or specific clinical indications—only that it complies with regulatory filings for its intended purpose.
Are there different sizes or models available for this contact lens case?
The provided data does not list specific size variations or model numbers beyond the GE Noryl 731-80089S. If multiple sizes exist, they would likely be differentiated by additional product codes or part numbers not included here. For exact sizing options, refer to the manufacturer’s catalog or technical specifications.