510(k) K921882

THE CLEANER ACCESSORY by Eaton Medical Corp. — Product Code LYL

K921882 is an FDA 510(k) premarket notification submitted by Eaton Medical Corp. for the device "THE CLEANER ACCESSORY". The FDA issued a decision of Substantially Equivalent on August 25, 1992. 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: August 25, 1992
Date Received: April 21, 1992
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 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)

510(k) K921882

Clearance Details

Device Classification

Other clearances by Eaton Medical Corp.

Other clearances for product code LYL

FDA data resources