Home / 510(k) Clearances / K860677

510(k) K860677

EASY EYES TM LENS CARRYING CASE by Applied Laboratories, Inc. — Product Code HPX

K860677 is an FDA 510(k) premarket notification submitted by Applied Laboratories, Inc. for the device "EASY EYES TM LENS CARRYING CASE". The FDA issued a decision of Substantially Equivalent on May 29, 1986. The device falls under product code HPX (Lens, Contact (Polymethylmethacrylate)), a Class U device. Applied Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1986
Date Received
February 25, 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 Applied Laboratories, Inc.

  • K873825 — GE LEXAN 144R 112 (March 24, 1988)
  • K873824 — RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000 (March 24, 1988)
  • K873820 — MOBAY (BAYER) MAKROLON 2658 1112 (March 24, 1988)
  • K873822 — MOBAY (BAYER) MERLON M-40 (H)F 1112 (March 24, 1988)
  • K873821 — GE NORYL 731-80089S (March 24, 1988)
  • K873823 — MOBAY (BAYER) MAKROLON 2658 3291 (March 24, 1988)
  • K871714 — KESTREL CONTACT LENS CASE (May 26, 1987)
  • K853870 — EASY EYES TM LENS CARRYING CASE (December 10, 1985)

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