Cleared Traditional

K930435 - SPECTACLE FRAMES

K930435 is an FDA 510(k) clearance for SPECTACLE FRAMES, manufactured by Venis DI A. Vendrame. The device is a Class 1 Ophthalmic device with product code HOI cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K930435 · Venis DI A. Vendrame · Ophthalmic device
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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

FDA 510(k) Submission Details - K930435

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.

HOI Device Classification - Class 1, General Controls

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.