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510(k) K895411

OPTIKEM PMMA CONTACT LENS by Optikem Polymers, Inc. — Product Code HPX

K895411 is an FDA 510(k) premarket notification submitted by Optikem Polymers, Inc. for the device "OPTIKEM PMMA CONTACT LENS". The FDA issued a decision of Substantially Equivalent on February 27, 1990. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1990
Date Received
September 6, 1989
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)
  • 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