Home / 510(k) Clearances / K133740

510(k) K133740

SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT by Sauflon Pharmaceuticals, Ltd. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2014
Date Received
December 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

Other clearances by Sauflon Pharmaceuticals, Ltd.

  • K130342 — SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER (August 5, 2013)
  • K130331 — SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT (July 26, 2013)
  • K130734 — SAUFLON MULTIPURPOSE SOLUTION (May 15, 2013)
  • K052832 — SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS (May 15, 2006)
  • K052809 — SAUFLON FLAT COLOURED LENS CASE (November 2, 2005)
  • K033656 — SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE (February 2, 2004)
  • K030278 — SAUFLON MULTIPURPOSE SOLUTION - NO RUB (July 30, 2003)
  • K013649 — SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS (December 26, 2001)
  • K010559 — SAUFLON MULTI LENS CARE SYSTEM (December 20, 2001)
  • K011456 — DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES (July 17, 2001)

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