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510(k) K913081

MULTI-VIEW BIFOCALS by Camp Contact Lenses — Product Code HPX

K913081 is an FDA 510(k) premarket notification submitted by Camp Contact Lenses for the device "MULTI-VIEW BIFOCALS". The FDA issued a decision of Substantially Equivalent on October 23, 1991. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1991
Date Received
July 8, 1991
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)
  • 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