Cleared Traditional

LENSOMETER MODEL 11 (K781440) - FDA 510(k) Clearance

Class I Ophthalmic device.

K781440 · Rodenstock Instrument Corp. · Ophthalmic device
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Sep 1978
Decision
20d
Days
Class 1
Risk

K781440 is an FDA 510(k) clearance for the LENSOMETER MODEL 11. Classified as Instrument, Measuring, Lens, Ac-powered (product code HLM), Class I - General Controls.

Submitted by Rodenstock Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1978 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1425 - 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 Rodenstock Instrument Corp. devices

Submission Details

510(k) Number K781440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1978
Decision Date September 07, 1978
Days to Decision 20 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 110d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLM Instrument, Measuring, Lens, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1425
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.