Home / 510(k) Clearances / K923435

510(k) K923435

CORNEAL TOPOGRAPHY SYSTEM by Par Microsystems Corp. — Product Code HLQ

K923435 is an FDA 510(k) premarket notification submitted by Par Microsystems Corp. for the device "CORNEAL TOPOGRAPHY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 16, 1993. The device falls under product code HLQ (Keratoscope, Ac-Powered), a Class I device regulated under 21 CFR 886.1350. Par Microsystems Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1993
Date Received
July 13, 1992
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 Par Microsystems Corp.

  • K870039 — IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM (February 12, 1987)

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)
  • K922253 — KERATOREF L60 (June 19, 1992)
  • K912740 — ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) (December 30, 1991)

FDA data resources