Cleared Traditional

K831084 - SUN PHOTO-KERATOSCOPE (FDA 510(k) Clearance)

Class I Ophthalmic device.

K831084 · Nidek, Inc. · Ophthalmic device
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Jun 1983
Decision
87d
Days
Class 1
Risk

K831084 is an FDA 510(k) clearance for the SUN PHOTO-KERATOSCOPE. Classified as Keratoscope, Ac-powered (product code HLQ), Class I - General Controls.

Submitted by Nidek, Inc. (Walker, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1350 - 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 Nidek, Inc. devices

Submission Details

510(k) Number K831084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1983
Decision Date June 30, 1983
Days to Decision 87 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 110d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLQ Keratoscope, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1350
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.