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510(k) K890687

ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER by Optimed, Inc. — Product Code HLQ

K890687 is an FDA 510(k) premarket notification submitted by Optimed, Inc. for the device "ECT-100 ELECTRONIC CORNEAL TOPOGRAPHER". The FDA issued a decision of Substantially Equivalent on September 5, 1989. The device falls under product code HLQ (Keratoscope, Ac-Powered), a Class I device regulated under 21 CFR 886.1350. Optimed, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1989
Date Received
February 9, 1989
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 Optimed, Inc.

  • K903462 — OPTIMED GLAUCOMA PRESSURE REGULATOR (October 16, 1990)
  • K884867 — OPTIFIELD I AND II AUTOMATED PERIMETERS (March 9, 1989)
  • K883458 — OPTIMED ADVANTAGE (November 7, 1988)

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)
  • 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