Cleared Traditional

K942533 - NOVALENS/NOVAWET PERCEPTION AND VANGUARD

K942533 is an FDA 510(k) clearance for NOVALENS/NOVAWET PERCEPTION AND VANGUARD, manufactured by Ocutec Corporation, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K942533 · Ocutec Corporation, Inc. · Ophthalmic device
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Aug 1994
Decision
70d
Days
Class 2
Risk

K942533 is an FDA 510(k) clearance for the NOVALENS/NOVAWET PERCEPTION AND VANGUARD. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Ocutec Corporation, Inc. (Morrisville, US). The FDA issued a Cleared decision on August 5, 1994 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5916 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ocutec Corporation, Inc. devices

FDA 510(k) Submission Details - K942533

510(k) Number K942533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1994
Decision Date August 05, 1994
Days to Decision 70 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 110d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQD Device Classification - Class 2, Special Controls

Product Code HQD Lens, Contact (other Material) - Daily
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5916
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQD Lens, Contact (other Material) - Daily

All 91
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K942533.
OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)
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BOSTON VII
K942365 · Polymer Technology Corp. · Jun 1994