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510(k) K033656

SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE by Sauflon Pharmaceuticals, Ltd. — Product Code LRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2004
Date Received
November 21, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Case, Contact Lens
Device Class
Class II
Regulation Number
886.5928
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)
  • 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 LRX

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  • K250495 — MINI VP1 (PL67_F); MINI VP1 (PL61_F) (August 1, 2025)
  • K240095 — CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) (October 9, 2024)
  • K231123 — Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Cas (August 30, 2023)
  • K173538 — Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (December 4, 2017)
  • K172925 — Contact Lens Case, Model: A-1, B-1 (November 30, 2017)
  • K173365 — Bausch + Lomb Boston Scleral Lens Case (November 17, 2017)
  • K171539 — Contact Lens Case (July 14, 2017)
  • K171163 — Contact Lens Case Round Glasses (June 27, 2017)
  • K162869 — Contact Lens Case (December 9, 2016)