Cleared Traditional

SPECTACLE FRAMES (K930597) - FDA 510(k) Clearance

Class I Ophthalmic device.

K930597 · Venis DI Alessandro Vendrame · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Aug 1993
Decision
178d
Days
Class 1
Risk

K930597 is an FDA 510(k) clearance for the SPECTACLE FRAMES. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Venis DI Alessandro Vendrame (Treviso, Italy, IT). The FDA issued a Cleared decision on August 2, 1993 after a review of 178 days - an extended review cycle.

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.

View all Venis DI Alessandro Vendrame devices

Submission Details

510(k) Number K930597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1993
Decision Date August 02, 1993
Days to Decision 178 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 110d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQZ Frame, Spectacle
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5842
What this classification means

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.