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510(k) K021699

AUTOLENS CLEANING AND DISINFECTING UNIT by Autolens, Inc. — Product Code LYL

K021699 is an FDA 510(k) premarket notification submitted by Autolens, Inc. for the device "AUTOLENS CLEANING AND DISINFECTING UNIT". The FDA issued a decision of Substantially Equivalent on December 16, 2002. The device falls under product code LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses), a Class II device regulated under 21 CFR 886.5928.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2002
Date Received
May 22, 2002
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

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  • K210300 — VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Clean (April 1, 2021)
  • K083757 — BPZ02 MULTIPURPOSE SOLUTION (November 18, 2009)
  • 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)
  • K964222 — ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING (December 20, 1996)

FDA data resources