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510(k) K901009

MODEL 2000 INTRAOPERATIVE CORNEASCOPE by Kera Corp. — Product Code HLQ

K901009 is an FDA 510(k) premarket notification submitted by Kera Corp. for the device "MODEL 2000 INTRAOPERATIVE CORNEASCOPE". The FDA issued a decision of Substantially Equivalent on May 30, 1990. The device falls under product code HLQ (Keratoscope, Ac-Powered), a Class I device regulated under 21 CFR 886.1350. Kera Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1990
Date Received
March 5, 1990
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 Kera Corp.

  • K871479 — VIDEOSCAN (TM) (May 22, 1987)
  • K864037 — KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER (November 13, 1986)
  • K850665 — CORNEASCOPE MODEL 1200 (March 20, 1985)

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