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510(k) K912740

ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) by Visionary Systems, Inc. — Product Code HLQ

K912740 is an FDA 510(k) premarket notification submitted by Visionary Systems, Inc. for the device "ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER)". The FDA issued a decision of Substantially Equivalent on December 30, 1991. The device falls under product code HLQ (Keratoscope, Ac-Powered), a Class I device regulated under 21 CFR 886.1350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1991
Date Received
June 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratoscope, Ac-Powered
Device Class
Class I
Regulation Number
886.1350
Review Panel
OP
Submission Type

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  • K973756 — EYE SYS VISTA (November 13, 1997)
  • K964290 — EYECHEK (January 9, 1997)
  • K945382 — TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER (January 31, 1995)
  • K944207 — TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 (December 7, 1994)
  • K944616 — KERATRON CORNEAL TOPOGRAPHER (November 22, 1994)
  • K940647 — ORBSCAN(TM) KERATOMETER (July 6, 1994)
  • K933556 — EH-270 CORNEAL TOPOGRAPHER (November 2, 1993)
  • K923435 — CORNEAL TOPOGRAPHY SYSTEM (February 16, 1993)
  • K922253 — KERATOREF L60 (June 19, 1992)

FDA data resources