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510(k) K053475

OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 by Refractec, Inc. — Product Code HMR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2006
Date Received
December 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Ocular
Device Class
Class I
Regulation Number
886.4570
Review Panel
OP
Submission Type

Other clearances by Refractec, Inc.

  • K980522 — REFRACTEC MCS-100 (July 22, 1998)

Other clearances for product code HMR

  • K925606 — OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS (August 29, 1994)
  • K872747 — LASER CENTERING DEVICE (September 4, 1987)
  • K863663 — OPHTHALMIC SURGICAL OCULAR MARKERS (October 20, 1986)
  • K861535 — OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU (May 14, 1986)