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510(k) K864343

BL1 (HARD CONTACT LENS) by Beta Labs, Inc. — Product Code HPX

K864343 is an FDA 510(k) premarket notification submitted by Beta Labs, Inc. for the device "BL1 (HARD CONTACT LENS)". The FDA issued a decision of Substantially Equivalent on November 28, 1986. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1986
Date Received
November 4, 1986
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)
  • K874591 — ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY (May 3, 1988)
  • K865111 — CHARTER HARD CONTACT LENS CLEANING SOLUTION (January 20, 1987)
  • 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