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510(k) K982115

LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY by Rim-Wide Companies, Inc. — Product Code LYL

K982115 is an FDA 510(k) premarket notification submitted by Rim-Wide Companies, Inc. for the device "LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY". The FDA issued a decision of Substantially Equivalent on January 13, 1999. 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
January 13, 1999
Date Received
June 16, 1998
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

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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)
  • 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)
  • 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