Cleared Traditional

K894557 - LIGHTSCOPE SET

K894557 is an FDA 510(k) clearance for LIGHTSCOPE SET, manufactured by Optik. The device is a Class 1 Neurology device with product code HRW cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K894557 · Optik · Neurology device
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Aug 1989
Decision
18d
Days
Class 1
Risk

K894557 is an FDA 510(k) clearance for the LIGHTSCOPE SET. Classified as Dynamometer, Nonpowered (product code HRW), Class I - General Controls.

Submitted by Optik (Criftib, US). The FDA issued a Cleared decision on August 7, 1989 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1250 - the FDA neurology 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 Optik devices

FDA 510(k) Submission Details - K894557

510(k) Number K894557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1989
Decision Date August 07, 1989
Days to Decision 18 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 148d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

HRW Device Classification - Class 1, General Controls

Product Code HRW Dynamometer, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1250
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.

Regulatory Peers - HRW Dynamometer, Nonpowered

All 8
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