Cleared Traditional

K861021 - GOTTEX SUNGLASSES

K861021 is the FDA 510(k) clearance for GOTTEX SUNGLASSES by Private Eyes Sunglass Corp.. It is a Class 1 Ophthalmic device (product code HQG) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K861021 · Private Eyes Sunglass Corp. · Ophthalmic device
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Jun 1986
Decision
91d
Days
Class 1
Risk

K861021 is an FDA 510(k) clearance for the GOTTEX SUNGLASSES. Classified as Lens, Spectacle, Non-custom (prescription) (product code HQG), Class I - General Controls.

Submitted by Private Eyes Sunglass Corp. (Norwell, US). The FDA issued a Cleared decision on June 17, 1986 after a review of 91 days - within the typical 510(k) review window.

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 Private Eyes Sunglass Corp. devices

Submission Details

510(k) Number K861021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date June 17, 1986
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 110d · This submission: 91d
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 K861021.
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