Class I Ophthalmic device.
K791112 is an FDA 510(k) clearance for the LIBCO 1,2,3, EYEGLASS FRAMES. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.
Submitted by Libco Eyewear, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1979.
This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5842 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.
| 510(k) Number | K791112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1979 |
| Decision Date | June 15, 1979 |
| Days to Decision | - |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Third-party Review | No - reviewed directly by FDA |
| Product Code | HQZ Frame, Spectacle |
| Device Class | Class 1 - General Controls |
| CFR Regulation | 21 CFR 886.5842 |
Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.
Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.