Home / 510(k) Clearances / K013649

510(k) K013649

SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS by Sauflon Pharmaceuticals, Ltd. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 2001
Date Received
November 5, 2001
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.

  • 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)
  • 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)
  • 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 LPL

  • K252385 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (March 13, 2026)
  • K254052 — DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (February 13, 2026)
  • K251683 — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Bl (December 23, 2025)
  • K250364 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contac (October 7, 2025)
  • K244009 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for (September 25, 2025)
  • K251095 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (September 17, 2025)
  • K251573 — VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (September 10, 2025)
  • K242855 — P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (July 30, 2025)
  • K243868 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (July 2, 2025)
  • K242056 — miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDEN (April 17, 2025)