HKO · Class I · 21 CFR 886.1760

FDA Product Code HKO: Refractometer, Ophthalmic

Leading manufacturers include Nidek, Inc., Canon USA, Inc. and Bausch & Lomb, Inc..

Total

Cleared

95d

Avg days

1977

Since

FDA 510(k) Cleared Refractometer, Ophthalmic Devices (Product Code HKO)

35 devices

1–24 of 35

AUTOREF LENSMETER RL-10

AR-1600G AUTO-REFRACTOMETER

NIDEK RT-1200S (MARCO TRS-1200)

CANON AUTOREFRACTOMETER R-22

CANON AUTOREFRACTOMETER R-20

BAUSCH & LOMB GR-3 REFRACTOR

AR-1100 AUTOMATIC REFRACTOR

AR-1600 AUTOMATIC REFRACTOR

AR-1000 AUTOMATIC REFRACTOR

I.V.E. REFRACTION SYSTEM

American Optical Corp.

Ophthalmic · 28d

Cleared Apr 23, 1981

SR-IV PROGRAMMED SUBJECTIVE REFRACTOR

K802183

American Optical Corp.

Ophthalmic · 226d

About Product Code HKO - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,730 total devices indexed.

Latest clearance: Dec 19, 2003

Product Code Info

Code	HKO
Device class	Class I
CFR	21 CFR 886.1760
Panel	Ophthalmic

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View HKO classification on FDA.gov →