Cleared Traditional

K842187 - MULTIPLE LENS

K842187 is the FDA 510(k) clearance for MULTIPLE LENS by Pavuna , Ltd.. It is a Class 1 Ophthalmic device (product code HQG) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K842187 · Pavuna , Ltd. · Ophthalmic device
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Dec 1984
Decision
190d
Days
Class 1
Risk

K842187 is an FDA 510(k) clearance for the MULTIPLE LENS, SPECTACLES, CUSTOM. Classified as Lens, Spectacle, Non-custom (prescription) (product code HQG), Class I - General Controls.

Submitted by Pavuna , Ltd.. The FDA issued a Cleared decision on December 11, 1984 after a review of 190 days - an extended review 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: 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 Pavuna , Ltd. devices

Submission Details

510(k) Number K842187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1984
Decision Date December 11, 1984
Days to Decision 190 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 110d · This submission: 190d
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 K842187.
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