Cleared Traditional

K851555 - OPTHALMIC BAR PRISM

K851555 is an FDA 510(k) clearance for OPTHALMIC BAR PRISM, manufactured by Roseburg SA. The device is a Class 1 Ophthalmic device with product code HKW cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K851555 · Roseburg SA · Ophthalmic device
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May 1985
Decision
37d
Days
Class 1
Risk

K851555 is an FDA 510(k) clearance for the OPTHALMIC BAR PRISM. Classified as Prism, Bar, Ophthalmic (product code HKW), Class I - General Controls.

Submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on May 23, 1985 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1650 - 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 - K851555

510(k) Number K851555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1985
Decision Date May 23, 1985
Days to Decision 37 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
73d faster than avg
Panel avg: 110d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

HKW Device Classification - Class 1, General Controls

Product Code HKW Prism, Bar, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1650
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.