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510(k) K944207

TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 by Computed Anatomy, Inc. — Product Code HLQ

K944207 is an FDA 510(k) premarket notification submitted by Computed Anatomy, Inc. for the device "TOPOGRAPHIC MODELING SYSTEM 2 TMS-2". The FDA issued a decision of Substantially Equivalent on December 7, 1994. The device falls under product code HLQ (Keratoscope, Ac-Powered), a Class I device regulated under 21 CFR 886.1350. Computed Anatomy, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1994
Date Received
August 29, 1994
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

Other clearances by Computed Anatomy, Inc.

  • K902012 — VKS-1 VIDEO KERATOSCOPE (June 22, 1990)
  • K901363 — TOPOGRAPHIC MODELING SYSTEM (May 25, 1990)
  • K862379 — CORNEAL MODELING SYSTEM (August 25, 1986)

Other clearances for product code HLQ

  • K003299 — OPD-SCAN, MODELS ARK-10000 AND ARK-9000 (March 9, 2001)
  • K973756 — EYE SYS VISTA (November 13, 1997)
  • K964290 — EYECHEK (January 9, 1997)
  • K945382 — TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER (January 31, 1995)
  • 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)
  • K912740 — ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) (December 30, 1991)

FDA data resources