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510(k) K940106

KERATOPLASTY SUTURING LENS by Visionary Technologies of Miami, Inc. — Product Code HPX

K940106 is an FDA 510(k) premarket notification submitted by Visionary Technologies of Miami, Inc. for the device "KERATOPLASTY SUTURING LENS". The FDA issued a decision of Substantially Equivalent on May 25, 1994. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device. Visionary Technologies of Miami, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1994
Date Received
January 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Polymethylmethacrylate)
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type

Other clearances by Visionary Technologies of Miami, Inc.

  • K940107 — VIRECTOMY LENS (September 6, 1994)

Other clearances for product code HPX

  • K955777 — PMMA CLASIC (May 16, 1996)
  • K913081 — MULTI-VIEW BIFOCALS (October 23, 1991)
  • K897021 — MARTIN-HENSLEY SEGMENT LENS (June 22, 1990)
  • K895411 — OPTIKEM PMMA CONTACT LENS (February 27, 1990)
  • K874591 — ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY (May 3, 1988)
  • K865111 — CHARTER HARD CONTACT LENS CLEANING SOLUTION (January 20, 1987)
  • K864343 — BL1 (HARD CONTACT LENS) (November 28, 1986)
  • K863974 — CHARTER LABORATORIES INC. LENS LUBRICANT (November 10, 1986)
  • K862952 — CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES (September 25, 1986)
  • K862811 — AQUALUX LENS CASE (September 3, 1986)

FDA data resources