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510(k) K904824

EASY EYES TM CONTACT LENS CLEANING MACHINE by Eaton Medical Corp. — Product Code LYL

K904824 is an FDA 510(k) premarket notification submitted by Eaton Medical Corp. for the device "EASY EYES TM CONTACT LENS CLEANING MACHINE". The FDA issued a decision of Substantially Equivalent on July 5, 1991. The device falls under product code LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses), a Class II device regulated under 21 CFR 886.5928. Eaton Medical Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1991
Date Received
October 25, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Solution, Ultrasonic Cleaners For Lenses
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

Other clearances by Eaton Medical Corp.

  • K931718 — SPIRIT SHIELD (September 20, 1993)
  • K921882 — THE CLEANER ACCESSORY (August 25, 1992)
  • K871741 — EASY EYES TM LENS CARRYING CASE (July 22, 1987)
  • K841881 — EASY EYES TM LENS CARRYING CASE (December 3, 1984)

Other clearances for product code LYL

  • K211361 — 3N Contact Lenses Adjunct Cleaner (January 13, 2022)
  • K210300 — VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Clean (April 1, 2021)
  • K083757 — BPZ02 MULTIPURPOSE SOLUTION (November 18, 2009)
  • K021699 — AUTOLENS CLEANING AND DISINFECTING UNIT (December 16, 2002)
  • K022687 — AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (November 19, 2002)
  • K020802 — RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION (May 31, 2002)
  • K994021 — CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION (February 22, 2000)
  • K991965 — PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES (October 1, 1999)
  • K982115 — LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY (January 13, 1999)
  • K974724 — SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS (March 2, 1998)

FDA data resources