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510(k) K874591

ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY by Vitreo Dynamics, Co. — Product Code HPX

K874591 is an FDA 510(k) premarket notification submitted by Vitreo Dynamics, Co. for the device "ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY". The FDA issued a decision of Substantially Equivalent on May 3, 1988. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1988
Date Received
November 9, 1987
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 for product code HPX

  • K955777 — PMMA CLASIC (May 16, 1996)
  • K940106 — KERATOPLASTY SUTURING LENS (May 25, 1994)
  • K913081 — MULTI-VIEW BIFOCALS (October 23, 1991)
  • K897021 — MARTIN-HENSLEY SEGMENT LENS (June 22, 1990)
  • K895411 — OPTIKEM PMMA CONTACT LENS (February 27, 1990)
  • 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