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510(k) K130331

SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER by Sauflon Pharmaceuticals, Ltd. — Product Code MVN

K130331 is an FDA 510(k) premarket notification submitted by Sauflon Pharmaceuticals, Ltd. for the device "SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER". The FDA issued a decision of Substantially Equivalent on July 26, 2013. The device falls under product code MVN (Lens, Contact, (Disposable)), a Class II device regulated under 21 CFR 886.5925. Sauflon Pharmaceuticals, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2013
Date Received
February 11, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, (Disposable)
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

Other clearances by Sauflon Pharmaceuticals, Ltd.

  • K133740 — SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULT (March 5, 2014)
  • K130342 — SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER (August 5, 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)

Other clearances for product code MVN

  • K261812 — HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina ( (July 7, 2026)
  • K202448 — DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal (September 22, 2020)
  • K202036 — Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaCo (August 21, 2020)
  • K150630 — Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily (June 15, 2015)
  • K143190 — Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens (January 16, 2015)
  • K112192 — NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS (October 25, 2011)
  • K080632 — CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS (October 15, 2008)
  • K080755 — SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (June 10, 2008)
  • K073060 — CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (November 29, 2007)
  • K061948 — PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS (November 22, 2006)

FDA data resources