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510(k) K991965

PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES by Purilens, Inc. — Product Code LYL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1999
Date Received
June 10, 1999
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 Purilens, Inc.

  • K002319 — PURILENS SALINE SOLUTION (August 30, 2000)

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  • 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)
  • 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)