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510(k) K964222

ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING by Paladin Medical, Inc. — Product Code LYL

K964222 is an FDA 510(k) premarket notification submitted by Paladin Medical, Inc. for the device "ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING". The FDA issued a decision of Substantially Equivalent on December 20, 1996. The device falls under product code LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses), a Class II device regulated under 21 CFR 886.5928. Paladin Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1996
Date Received
October 22, 1996
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 Paladin Medical, Inc.

  • K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4 (November 3, 1999)
  • K970347 — MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM (August 29, 1997)
  • K971290 — STRATASYS FDM MEDMODELER SYSTEM (June 20, 1997)
  • K950054 — ENDO-BEND(TM) SHAVER (June 29, 1995)
  • K935220 — CORE PREVENT MATTRESS MODIFICATION (November 29, 1993)
  • K921015 — SHARPE ENDOSPONGE ASPIIRATOR (May 21, 1993)
  • K915743 — SHARPE ENDOTENACULUM (May 20, 1993)
  • K915747 — SHARPE ENDOFORCEPS (October 20, 1992)
  • K915749 — SHARPE ENDOLIGATURE CARRIER (October 20, 1992)
  • K915744 — SHARPE ENDOHEMOSTAT (October 20, 1992)

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