Cleared Traditional

SENSORY 6 (K862338) - FDA 510(k) Clearance

Class I Ophthalmic device.

K862338 · Brytech, Inc. · Ophthalmic device
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Sep 1986
Decision
75d
Days
Class 1
Risk

K862338 is an FDA 510(k) clearance for the SENSORY 6. Classified as Aid, Vision, Electronic, Battery-powered (product code HPG), Class I - General Controls.

Submitted by Brytech, Inc. (Canada, CA). The FDA issued a Cleared decision on September 3, 1986 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5900 - 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 Brytech, Inc. devices

Submission Details

510(k) Number K862338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1986
Decision Date September 03, 1986
Days to Decision 75 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 110d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPG Aid, Vision, Electronic, Battery-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5900
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.