HKO · Class I · 21 CFR 886.1760

FDA Product Code HKO: Refractometer, Ophthalmic

Leading manufacturers include Nidek, Inc., Canon USA, Inc. and American Optical Corp..

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

BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8

BURTON AUTO REFRACTOR - MODEL BAR-7

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

Cleared Sep 07, 1978

AUTOREFRACTOR, SUBJECTIVE

SUBJECTIVE REFRACTOR, MOSEL SR-111

K771914

American Optical Corp.

Ophthalmic · 28d

About Product Code HKO - Regulatory Context

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,972 total devices indexed.

Latest clearance: Dec 19, 2003

Product Code Info

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

Verify on FDA.gov

View HKO classification on FDA.gov →