Cleared Traditional

K870178 - SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS

K870178 is an FDA 510(k) clearance for SUNGLASSES AND SUNGLASS FRAMES VARIOUS ..., manufactured by Polinelli. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K870178 · Polinelli · Ophthalmic device
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Apr 1987
Decision
91d
Days
Class 1
Risk

K870178 is an FDA 510(k) clearance for the SUNGLASSES AND SUNGLASS FRAMES VARIOUS COLORS. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Polinelli (Via Belvedere, 18, IT). The FDA issued a Cleared decision on April 16, 1987 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 886.5850 - 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 Polinelli devices

FDA 510(k) Submission Details - K870178

510(k) Number K870178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1987
Decision Date April 16, 1987
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.

HQY Device Classification - Class 1, General Controls

Product Code HQY Sunglasses (non-prescription Including Photosensitive)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5850
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 - HQY Sunglasses (non-prescription Including Photosensitive)

All 124
Devices cleared under the same product code (HQY) and FDA review panel - the closest regulatory comparables to K870178.
PHOTOCHROMIC LENS
K890725 · Ppg Industries, Inc. · Apr 1989
CALIUS-ISABEL CANOVAS SUNGLASSES
K890081 · Roseburg SA · Mar 1989
ASSENAT-BLESCHET SUNGLASSES
K885275 · Roseburg SA · Jan 1989
SUNGLASSES (NON-PRESCRIPTION)
K860953 · Roseburg SA · Oct 1986
RAY-BAN SUN GLASSES
K791499 · Bausch & Lomb, Inc. · Aug 1979