Cleared Traditional

K852403 - AURALITE II

K852403 is the FDA 510(k) clearance for AURALITE II by Aura Lens Products. It is a Class 1 Ophthalmic device (product code HQG) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K852403 · Aura Lens Products · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
75d
Days
Class 1
Risk

K852403 is an FDA 510(k) clearance for the AURALITE II. Classified as Lens, Spectacle, Non-custom (prescription) (product code HQG), Class I - General Controls.

Submitted by Aura Lens Products (St. Cloud, US). The FDA issued a Cleared decision on August 20, 1985 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5844 - 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 Aura Lens Products devices

Submission Details

510(k) Number K852403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1985
Decision Date August 20, 1985
Days to Decision 75 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 110d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HQG Lens, Spectacle, Non-custom (prescription)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5844
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.

Regulatory Peers - HQG Lens, Spectacle, Non-custom (prescription)

All 7
Devices cleared under the same product code (HQG) and FDA review panel - the closest regulatory comparables to K852403.
FORMALENS 2000
K863367 · Vision-Sciences, Inc. · Sep 1986
CORNING CPF 550 LENS
K821398 · Corning Medical & Scientific · Jun 1982
PHOTOLITE AOLITE TINTOMATIC LENS
K812051 · American Optical Corp. · Sep 1981
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
K802651 · Chiron Vision Corp. · Dec 1980
ULTRAVUE BLENDED BIFOCAL LENS
K791721 · American Optical Corp. · Oct 1979
FUL-VUE ASPHERIC CATARACT LENS
K790251 · American Optical Corp. · Feb 1979