ACT-1 (Anterior Corneal Topographer)

FDA 510(k) K912740 · Visionary Systems, Inc.

Substantially Equivalent

510(k) numberK912740

Submission

Device name
ACT-1 (Anterior Corneal Topographer)
Applicant
Visionary Systems, Inc.
Tucson, AZ, US
Received
June 21, 1991
Decision date
December 30, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HLQ – Keratoscope, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 886.1350
Specialty
Ophthalmic

Other 510(k)s with product code HLQ

510(k)DeviceApplicantDecision
K003299Opd-Scan, Models ARK-10000 and ARK-9000HLQ · Traditional Nidek Co., Ltd.03/09/2001SESU
K973756Eye Sys VistaHLQ · Traditional Eyesys Technologies, Inc.11/13/1997SE
K964290EyechekHLQ · Traditional Reichert Ophthalmic Instruments, Div. Leica, Inc.01/09/1997SE
K945382Technomed C-Scan Color Ellipsoid TopometerHLQ · Traditional Expertech Assoc., Inc.01/31/1995SE
K944207Topographic Modeling System 2 TMS-2HLQ · Traditional Computed Anatomy, Inc.12/07/1994SE
K944616Keratron Corneal TopographerHLQ · Traditional Alliance Medical Marketinig11/22/1994SE
K940647Orbscan(Tm) KeratometerHLQ · Traditional Orbtek, Inc.07/06/1994SE
K933556EH-270 Corneal TopographerHLQ · Traditional Visioptic, Inc.11/02/1993SE
K923435Corneal Topography SystemHLQ · Traditional Par Microsystems Corp.02/16/1993SE
K922253Keratoref L60HLQ · Traditional Luneau Ophtalmologie SA06/19/1992SE

Questions and answers

When was ACT-1 (Anterior Corneal Topographer) cleared by the FDA?

ACT-1 (Anterior Corneal Topographer) (K912740) received a 510(k) decision of Substantially Equivalent on December 30, 1991, 192 days after the submission was received.

What is the product code of K912740?

The FDA product code is HLQ – Keratoscope, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1350.