Cleared Traditional

K812051 - PHOTOLITE AOLITE TINTOMATIC LENS

K812051 is an FDA 510(k) clearance for PHOTOLITE AOLITE TINTOMATIC LENS, manufactured by American Optical Corp.. The device is a Class 1 Ophthalmic device with product code HQG cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K812051 · American Optical Corp. · Ophthalmic device
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Sep 1981
Decision
49d
Days
Class 1
Risk

K812051 is an FDA 510(k) clearance for the PHOTOLITE AOLITE TINTOMATIC LENS. Classified as Lens, Spectacle, Non-custom (prescription) (product code HQG), Class I - General Controls.

Submitted by American Optical Corp. (Walker, US). The FDA issued a Cleared decision on September 8, 1981 after a review of 49 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.

FDA 510(k) Submission Details - K812051

510(k) Number K812051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1981
Decision Date September 08, 1981
Days to Decision 49 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 110d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

HQG Device Classification - Class 1, General Controls

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 53
Devices cleared under the same product code (HQG) and FDA review panel - the closest regulatory comparables to K812051.
CORNING CPF 550 LENS
K821398 · Corning Medical & Scientific · Jun 1982
SUNGLASSES
K813130 · Panlin Corp. · Mar 1982
DI-CROWN
K812441 · Coburn Optical Ind., Inc. · Oct 1981
BARNES-HIND SPECTACLE LENS CLEANER
K811554 · Barnes-Hind, Inc. · Jul 1981
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC)
K802651 · Chiron Vision Corp. · Dec 1980
BARNES-HIND WETTING & SOAKING SOLUTION
K791901 · Barnes-Hind, Inc. · Nov 1979
K812051 · PHOTOLITE AOLITE TINTOMATIC LENS
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