Cleared Traditional

K860954 - SPECTACLES FRAME

K860954 is an FDA 510(k) clearance for SPECTACLES FRAME, manufactured by Roseburg SA. The device is a Class 1 Ophthalmic device with product code HQZ cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K860954 · Roseburg SA · Ophthalmic device
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Mar 1986
Decision
18d
Days
Class 1
Risk

K860954 is an FDA 510(k) clearance for the SPECTACLES FRAME. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on March 31, 1986 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5842 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roseburg SA devices

FDA 510(k) Submission Details - K860954

510(k) Number K860954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1986
Decision Date March 31, 1986
Days to Decision 18 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
92d faster than avg
Panel avg: 110d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

HQZ Device Classification - Class 1, General Controls

Product Code HQZ Frame, Spectacle
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5842
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.