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510(k) K230954

Samfilcon B Custom Contact Lens by Bausch + Lomb, Incorporated — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2023
Date Received
April 4, 2023
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 Bausch + Lomb, Incorporated

  • K211786 — Independent Corneal Viewing Chamber (IVC-21) (December 3, 2021)
  • K200528 — Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Sof (June 2, 2020)
  • K171404 — BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) (July 17, 2017)

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  • K244009 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for (September 25, 2025)
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  • 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)