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510(k) K850665

CORNEASCOPE MODEL 1200 by Kera Corp. — Product Code HLQ

K850665 is an FDA 510(k) premarket notification submitted by Kera Corp. for the device "CORNEASCOPE MODEL 1200". The FDA issued a decision of Substantially Equivalent on March 20, 1985. 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
March 20, 1985
Date Received
February 20, 1985
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.

  • K901009 — MODEL 2000 INTRAOPERATIVE CORNEASCOPE (May 30, 1990)
  • K871479 — VIDEOSCAN (TM) (May 22, 1987)
  • K864037 — KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER (November 13, 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)
  • 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