Cleared Traditional

K860953 - SUNGLASSES (NON-PRESCRIPTION)

K860953 is an FDA 510(k) clearance for SUNGLASSES (NON-PRESCRIPTION), manufactured by Roseburg SA. The device is a Class 1 Ophthalmic device with product code HQY cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K860953 · Roseburg SA · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1986
Decision
225d
Days
Class 1
Risk

K860953 is an FDA 510(k) clearance for the SUNGLASSES (NON-PRESCRIPTION). Classified as Sunglasses (non-prescription Including Photosensitive) (product code HQY), Class I - General Controls.

Submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on October 24, 1986 after a review of 225 days - an extended review cycle.

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 Roseburg SA devices

FDA 510(k) Submission Details - K860953

510(k) Number K860953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1986
Decision Date October 24, 1986
Days to Decision 225 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
115d slower than avg
Panel avg: 110d · This submission: 225d
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.