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510(k) K950077

INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) by Par Vision Systems Corp. — Product Code MMQ

K950077 is an FDA 510(k) premarket notification submitted by Par Vision Systems Corp. for the device "INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS)". The FDA issued a decision of Substantially Equivalent on June 14, 1995. The device falls under product code MMQ (Topographer, Corneal, Ac-Powered), a Class I device regulated under 21 CFR 886.1350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1995
Date Received
January 10, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Topographer, Corneal, Ac-Powered
Device Class
Class I
Regulation Number
886.1350
Review Panel
OP
Submission Type

Other clearances for product code MMQ

  • K981665 — SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE (December 7, 1998)
  • K964702 — EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 (May 20, 1997)
  • K964891 — ORBSHOT KERATOMETER (March 26, 1997)
  • K963762 — CORNEAL TOPOGRAPHER 200 (December 23, 1996)

FDA data resources