Home / 510(k) Clearances / K974724

510(k) K974724

SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT by Lens Comfort, Inc. — Product Code LYL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1998
Date Received
December 18, 1997
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 Lens Comfort, Inc.

  • K962112 — NEW COMFORT CONTACT LENS CARE ACCESSORY (November 29, 1996)

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  • K020802 — RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION (May 31, 2002)
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  • K982115 — LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY (January 13, 1999)
  • K964222 — ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING (December 20, 1996)