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510(k) K940647

ORBSCAN(TM) KERATOMETER by Orbtek, Inc. — Product Code HLQ

K940647 is an FDA 510(k) premarket notification submitted by Orbtek, Inc. for the device "ORBSCAN(TM) KERATOMETER". The FDA issued a decision of Substantially Equivalent on July 6, 1994. The device falls under product code HLQ (Keratoscope, Ac-Powered), a Class I device regulated under 21 CFR 886.1350. Orbtek, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1994
Date Received
February 15, 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 Orbtek, Inc.

  • K964891 — ORBSHOT KERATOMETER (March 26, 1997)

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)
  • 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