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510(k) K895741

CLAS PHOTOKERATOSCOPE by Kera-Metrics Corp. — Product Code HLQ

K895741 is an FDA 510(k) premarket notification submitted by Kera-Metrics Corp. for the device "CLAS PHOTOKERATOSCOPE". The FDA issued a decision of Substantially Equivalent on July 11, 1990. The device falls under product code HLQ (Keratoscope, Ac-Powered), a Class I device regulated under 21 CFR 886.1350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1990
Date Received
September 26, 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

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  • 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