Product Code: HLQ FDA class 1 21 CFR 886.1350

Keratoscope, Ac-Powered

Ophthalmic

The AC-Powered Keratoscope is an electrically powered ophthalmic instrument used to examine and measure the curvature and regularity of the corneal surface by projecting concentric rings or a disc pattern onto the cornea and observing the reflected image. 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 HLQ, regulated under 21 CFR 886.1350, 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

Years Active

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Basic Information

Product Code: HLQ
Device Class: FDA class 1
Regulation Number: 886.1350
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 29 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K003299	OPD-SCAN, MODELS ARK-10000 AND ARK-9000	Mar 09, 2001	Unknown	Nidek Co., Ltd.
K973756	EYE SYS VISTA	Nov 13, 1997	Substantially Equivalent	Eyesys Technologies, Inc.
K964290	EYECHEK	Jan 09, 1997	Substantially Equivalent	Reichert Ophthalmic Instruments, Div. Leica, Inc.
K945382	TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER	Jan 31, 1995	Substantially Equivalent	Expertech Assoc., Inc.
K944207	TOPOGRAPHIC MODELING SYSTEM 2 TMS-2	Dec 07, 1994	Substantially Equivalent	Computed Anatomy, Inc.
K944616	KERATRON CORNEAL TOPOGRAPHER	Nov 22, 1994	Substantially Equivalent	Alliance Medical Marketinig
K940647	ORBSCAN(TM) KERATOMETER	Jul 06, 1994	Substantially Equivalent	Orbtek, Inc.
K933556	EH-270 CORNEAL TOPOGRAPHER	Nov 02, 1993	Substantially Equivalent	Visioptic, Inc.
K923435	CORNEAL TOPOGRAPHY SYSTEM	Feb 16, 1993	Substantially Equivalent	Par Microsystems Corp.
K922253	KERATOREF L60	Jun 19, 1992	Substantially Equivalent	Luneau Ophtalmologie SA
K912740	ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER)	Dec 30, 1991	Substantially Equivalent	Visionary Systems, Inc.
K913022	CCI VIDEOKERATOSCOPE/COMPARATOR	Oct 09, 1991	Substantially Equivalent	Cci
K912130	TBD KERATOSCOPE	Aug 09, 1991	Substantially Equivalent	Alcon Laboratories
K895741	CLAS PHOTOKERATOSCOPE	Jul 11, 1990	Substantially Equivalent	Kera-Metrics Corp.
K902012	VKS-1 VIDEO KERATOSCOPE	Jun 22, 1990	Substantially Equivalent	Computed Anatomy, Inc.
K901009	MODEL 2000 INTRAOPERATIVE CORNEASCOPE	May 30, 1990	Substantially Equivalent	Kera Corp.
K901363	TOPOGRAPHIC MODELING SYSTEM	May 25, 1990	Substantially Equivalent	Computed Anatomy, Inc.
K895475	CANON AUTO REF-KERATOMETER RK-2	Oct 31, 1989	Substantially Equivalent	Canon USA, Inc.
K890687	ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER	Sep 05, 1989	Substantially Equivalent	Optimed, Inc.
K871936	CANON SURGICAL AUTO KERATOMETER SK-1	Jun 19, 1987	Substantially Equivalent	Canon USA, Inc.
K871479	VIDEOSCAN (TM)	May 22, 1987	Substantially Equivalent	Kera Corp.
K862137	NIDEK KM-1000 SURGICAL KERATOMETER	Jul 23, 1986	Substantially Equivalent	Nidek, Inc.
K861063	NIDEK KM-800 AUTO KERATOMETER	Apr 04, 1986	Substantially Equivalent	Nidek, Inc.
K853723	ZEISS OPERATING KERATOMETER	Oct 15, 1985	Substantially Equivalent	Carl Zeiss, Inc.
K853668	ORC ORACLE	Oct 15, 1985	Substantially Equivalent	Optical Radiation Corp.
K850665	CORNEASCOPE MODEL 1200	Mar 20, 1985	Substantially Equivalent	Kera Corp.
K841765	WOODLYN STANDARD SLIT LAMP HSSL-ST	Aug 07, 1984	Substantially Equivalent	Woodlyn, Inc.
K831084	SUN PHOTO-KERATOSCOPE	Jun 30, 1983	Substantially Equivalent	Nidek, Inc.
K781994	AUTOKERATOMETER, INSTRUMENT	Feb 12, 1979	Substantially Equivalent	Zeiss Humphrey System