Cleared Traditional

K862521 - BAUSCH & LOMB GR-3 REFRACTOR

K862521 is the FDA 510(k) clearance for BAUSCH & LOMB GR-3 REFRACTOR by Bausch & Lomb, Inc.. It is a Class 1 Ophthalmic device (product code HKO) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K862521 · Bausch & Lomb, Inc. · Ophthalmic device
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Jul 1986
Decision
10d
Days
Class 1
Risk

K862521 is an FDA 510(k) clearance for the BAUSCH & LOMB GR-3 REFRACTOR. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on July 11, 1986 after a review of 10 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 K862521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1986
Decision Date July 11, 1986
Days to Decision 10 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 110d · This submission: 10d
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.

Regulatory Peers - HKO Refractometer, Ophthalmic

All 13
Devices cleared under the same product code (HKO) and FDA review panel - the closest regulatory comparables to K862521.
CANON AUTOREFRACTOMETER R-22
K883200 · Canon USA, Inc. · Aug 1988
NIDEK ARK-2000
K882191 · Nidek, Inc. · Jul 1988
CANON AUTOREFRACTOMETER R-20
K882287 · Canon USA, Inc. · Jul 1988
AR-1100 AUTOMATIC REFRACTOR
K861065 · Nidek, Inc. · Apr 1986
AR-1600 AUTOMATIC REFRACTOR
K861062 · Nidek, Inc. · Apr 1986
AR-1000 AUTOMATIC REFRACTOR
K861066 · Nidek, Inc. · Apr 1986