Cleared Traditional

K813130 - SUNGLASSES

K813130 is an FDA 510(k) clearance for SUNGLASSES, manufactured by Panlin Corp.. The device is a Class 1 Ophthalmic device with product code HQG cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K813130 · Panlin Corp. · Ophthalmic device
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Mar 1982
Decision
119d
Days
Class 1
Risk

K813130 is an FDA 510(k) clearance for the SUNGLASSES. Classified as Lens, Spectacle, Non-custom (prescription) (product code HQG), Class I - General Controls.

Submitted by Panlin Corp. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1982 after a review of 119 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.

FDA 510(k) Submission Details - K813130

510(k) Number K813130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1981
Decision Date March 04, 1982
Days to Decision 119 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
9d slower than avg
Panel avg: 110d · This submission: 119d
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 50
Devices cleared under the same product code (HQG) and FDA review panel - the closest regulatory comparables to K813130.
NOSITE UV INTERIM SPECTACLES
K823825 · Patton, Boggs & Blow · Feb 1983
SUNGLASS LENSES
K822573 · ZEISS · Oct 1982
CORNING CPF 550 LENS
K821398 · Corning Medical & Scientific · Jun 1982
DI-CROWN
K812441 · Coburn Optical Ind., Inc. · Oct 1981
PHOTOLITE AOLITE TINTOMATIC LENS
K812051 · American Optical Corp. · Sep 1981
BARNES-HIND SPECTACLE LENS CLEANER
K811554 · Barnes-Hind, Inc. · Jul 1981
K813130 · SUNGLASSES
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