Cleared Traditional

I.V.E. REFRACTION SYSTEM (K812896) - FDA 510(k) Clearance

Class I Ophthalmic device.

K812896 · Bausch & Lomb, Inc. · Ophthalmic device
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Dec 1981
Decision
48d
Days
Class 1
Risk

K812896 is an FDA 510(k) clearance for the I.V.E. REFRACTION SYSTEM. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1981 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1760 - 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 Bausch & Lomb, Inc. devices

Submission Details

510(k) Number K812896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1981
Decision Date December 02, 1981
Days to Decision 48 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 110d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKO Refractometer, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1760
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.