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510(k) K864037

KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER by Kera Corp. — Product Code HJB

K864037 is an FDA 510(k) premarket notification submitted by Kera Corp. for the device "KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER". The FDA issued a decision of Substantially Equivalent on November 13, 1986. The device falls under product code HJB (Instrument, Measuring, Corneal Radius), a Class I device regulated under 21 CFR 886.1450. Kera Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1986
Date Received
October 16, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Measuring, Corneal Radius
Device Class
Class I
Regulation Number
886.1450
Review Panel
OP
Submission Type

Other clearances by Kera Corp.

  • K901009 — MODEL 2000 INTRAOPERATIVE CORNEASCOPE (May 30, 1990)
  • K871479 — VIDEOSCAN (TM) (May 22, 1987)
  • K850665 — CORNEASCOPE MODEL 1200 (March 20, 1985)

Other clearances for product code HJB

  • K930444 — MARCO STANDARD KERATOMETERS (August 9, 1993)
  • K924779 — BURTON KERATOMETER - MODLE 2040 (April 5, 1993)
  • K864369 — LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER (December 15, 1986)
  • K852424 — ACUFEX COMPARATIVE SURGICAL KERATOMETER (September 11, 1985)

FDA data resources