Cleared Traditional

K851698 - ANNE MARIE PERRIS SUNGLASSES AND FRAMES

K851698 is an FDA 510(k) clearance for ANNE MARIE PERRIS SUNGLASSES AND FRAMES, manufactured by Perlinea Co.. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K851698 · Perlinea Co. · Ophthalmic device
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Jul 1985
Decision
98d
Days
Class 1
Risk

K851698 is an FDA 510(k) clearance for the ANNE MARIE PERRIS SUNGLASSES AND FRAMES. Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Perlinea Co. (Ravenna, Italy, IT). The FDA issued a Cleared decision on July 31, 1985 after a review of 98 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 Perlinea Co. devices

FDA 510(k) Submission Details - K851698

510(k) Number K851698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1985
Decision Date July 31, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 110d · This submission: 98d
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.