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510(k) K862811

AQUALUX LENS CASE by Safeway Products, Inc. — Product Code HPX

K862811 is an FDA 510(k) premarket notification submitted by Safeway Products, Inc. for the device "AQUALUX LENS CASE". The FDA issued a decision of Substantially Equivalent on September 3, 1986. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device. Safeway Products, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1986
Date Received
July 24, 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 by Safeway Products, Inc.

  • K891508 — PATIENT EXAMINATION GLOVES (LATEX) (April 6, 1989)
  • K822828 — SOFT LENS THERMAL DISINFECTING UNIT, A-C (October 29, 1982)

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)
  • 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)

FDA data resources