Cleared Traditional

K890081 - CALIUS-ISABEL CANOVAS SUNGLASSES

K890081 is an FDA 510(k) clearance for CALIUS-ISABEL CANOVAS SUNGLASSES, 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 58-day FDA review.

K890081 · Roseburg SA · Ophthalmic device
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Mar 1989
Decision
58d
Days
Class 1
Risk

K890081 is an FDA 510(k) clearance for the CALIUS-ISABEL CANOVAS SUNGLASSES. 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 March 9, 1989 after a review of 58 days - a notably fast clearance 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: 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 - K890081

510(k) Number K890081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1989
Decision Date March 09, 1989
Days to Decision 58 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
52d faster than avg
Panel avg: 110d · This submission: 58d
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.