Product Code: HKO FDA class 1 21 CFR 886.1760

Refractometer, Ophthalmic

Ophthalmic

The Ophthalmic Refractometer is an instrument used to measure the refractive index of ocular fluids or to objectively determine refractive error of the eye, aiding in the diagnosis of conditions such as myopia, hyperopia, and astigmatism. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without a premarket notification requirement. The product code is HKO, regulated under 21 CFR 886.1760, within the Ophthalmic medical specialty. No special risk flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: HKO
Device Class: FDA class 1
Regulation Number: 886.1760
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 35 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K031831	TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM	Dec 19, 2003	Substantially Equivalent	Topcon Medical Systems, Inc.
K000327	WAVESCAN WAVEFRONT SYSTEM MODEL HS 1	May 02, 2000	Unknown	Visx, Incorporated
K951179	DIGITAL RETINOSCOPIC PHOTOMETER	May 30, 1995	Substantially Equivalent	Kudi Kalu, Inc.
K945959	VIDEO VISION ANALYZER (VIVA), VRB 100	Mar 01, 1995	Substantially Equivalent	Tomey Corporation USA
K942242	AUTO REF-KERATOMETER, RK-3	Sep 02, 1994	Substantially Equivalent	Cannon U.S.A., Inc.
K940516	AUTO REFF-30	Jul 12, 1994	Substantially Equivalent	Canon, Inc.
K925304	AUTOREF LENSMETER RL-10	Feb 17, 1994	Substantially Equivalent	Canon USA, Inc.
K924741	OPTEC 3000	Apr 06, 1993	Substantially Equivalent	Stereo Optical Co., Inc.
K924790	BURTON AUTO REFRACTOR - MODEL BAR-7	Apr 05, 1993	Substantially Equivalent	R.H. Burton Co.
K924778	BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8	Apr 05, 1993	Substantially Equivalent	R.H. Burton Co.
K904828	OPTEC 2300 AFVT, ARMED FORCES VISION TESTER	Jan 18, 1991	Substantially Equivalent	Stereo Optical Co., Inc.
K902500	AR-1600G AUTO-REFRACTOMETER	Jul 27, 1990	Substantially Equivalent	Nidek, Inc.
K901583	SHIN NIPPON AUTO REFRACTOMETER QR-007N	Jun 22, 1990	Substantially Equivalent	Soderberg, Inc.
K901513	NIDEK RT-1200S (MARCO TRS-1200)	Jun 08, 1990	Substantially Equivalent	Nidek, Inc.
K890559	NIDEK AR-1200	Feb 27, 1989	Substantially Equivalent	Nidek, Inc.
K883200	CANON AUTOREFRACTOMETER R-22	Aug 18, 1988	Substantially Equivalent	Canon USA, Inc.
K882287	CANON AUTOREFRACTOMETER R-20	Jul 01, 1988	Substantially Equivalent	Canon USA, Inc.
K882191	NIDEK ARK-2000	Jul 01, 1988	Substantially Equivalent	Nidek, Inc.
K871611	ALLERGAN HUMPHREY AUTO-REFRACTOR, MODELS 525 & 540	May 18, 1987	Substantially Equivalent	Allergan Humphrey
K862521	BAUSCH & LOMB GR-3 REFRACTOR	Jul 11, 1986	Substantially Equivalent	Bausch & Lomb, Inc.
K861065	AR-1100 AUTOMATIC REFRACTOR	Apr 09, 1986	Substantially Equivalent	Nidek, Inc.
K861066	AR-1000 AUTOMATIC REFRACTOR	Apr 04, 1986	Substantially Equivalent	Nidek, Inc.
K861062	AR-1600 AUTOMATIC REFRACTOR	Apr 04, 1986	Substantially Equivalent	Nidek, Inc.
K843042	VISION TESTER	Oct 05, 1984	Substantially Equivalent	Stereo Optical Co., Inc.
K841861	CANON AUTOREF R-10	Oct 05, 1984	Substantially Equivalent	Canon USA, Inc.
K831083	AUTO REFRACTOMETER	Jun 10, 1983	Substantially Equivalent	Nidek, Inc.
K820877	AUTOMATIC OBJECTIVE REFRACTOR 2000	Jun 25, 1982	Substantially Equivalent	Dicon, Inc.
K812896	I.V.E. REFRACTION SYSTEM	Dec 02, 1981	Substantially Equivalent	Bausch & Lomb, Inc.
K812063	SR-1V DATA PRINTER	Aug 18, 1981	Substantially Equivalent	American Optical Corp.
K802958	AUTO REFRACTOMETER NR-1000	Apr 23, 1981	Substantially Equivalent	Nippon Kogaku, Inc.
K802183	SR-IV PROGRAMMED SUBJECTIVE REFRACTOR	Apr 23, 1981	Substantially Equivalent	American Optical Corp.
K802029	OBJECTIVE REFRACTOR	Nov 12, 1980	Substantially Equivalent	Zeiss Humphrey System
K801906	DIOPTRON III AUTOREFRACTOR	Aug 27, 1980	Substantially Equivalent	Coherent Medical Division
K781014	AUTOREFRACTOR, SUBJECTIVE	Sep 07, 1978	Substantially Equivalent	Cavitron Corp.
K771914	SUBJECTIVE REFRACTOR, MOSEL SR-111	Nov 09, 1977	Substantially Equivalent	American Optical Corp.