Cleared Traditional

SPECTACLE FRAMES (K930435) - FDA 510(k) Clearance

Class I Ophthalmic device.

K930435 · Venis DI A. Vendrame · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
237d
Days
Class 1
Risk

K930435 is an FDA 510(k) clearance for the SPECTACLE FRAMES. Classified as Spectacle, Magnifying (product code HOI), Class I - General Controls.

Submitted by Venis DI A. Vendrame (Treviso, Italy, IT). The FDA issued a Cleared decision on September 20, 1993 after a review of 237 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5840 - 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 A. Vendrame devices

Submission Details

510(k) Number K930435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date September 20, 1993
Days to Decision 237 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
127d slower than avg
Panel avg: 110d · This submission: 237d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOI Spectacle, Magnifying
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5840
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.