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510(k) K253795

MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution by Menicon Co, Ltd. — Product Code LPN

K253795 is an FDA 510(k) premarket notification submitted by Menicon Co, Ltd. for the device "MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution". The FDA issued a decision of Substantially Equivalent on August 13, 2026. The device falls under product code LPN (Accessories, Soft Lens Products), a Class II device regulated under 21 CFR 886.5928. Menicon Co, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2026
Date Received
November 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Soft Lens Products
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

Other clearances by Menicon Co, Ltd.

  • K193399 — Miru 1day UpSide (midafilcon A) (June 17, 2020)
  • K191872 — Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (March 2, 2020)
  • K180819 — One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens (May 16, 2018)
  • K180004 — Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens (February 22, 2018)
  • K173136 — Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses (November 16, 2017)
  • K151768 — Menicon Saline Rinse Solution (August 28, 2015)
  • K130805 — MENICON UNIQUE PH MULTI-PURPOSE SOLUTION (July 3, 2013)
  • K122273 — MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS (January 2, 2013)
  • K102895 — ONE DAY FLAT PACK (April 28, 2011)
  • K103561 — MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS (February 3, 2011)

Other clearances for product code LPN

  • K222541 — Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (December 6, 2022)
  • K221263 — Aqua Naina Plus Sterile Saline Solution (October 12, 2022)
  • K202932 — ABT12 multi-purpose solution (May 28, 2021)
  • K210051 — OTE MPS 045 Multi-purpose Lens Care Solution (May 26, 2021)
  • K193441 — Aqua Naina Sterile Saline Solution (May 26, 2020)
  • K200747 — PuriLens Plus Preservative Free Saline (May 15, 2020)
  • K191872 — Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (March 2, 2020)
  • K190674 — REFRESH RELIEVA For CONTACTS (August 8, 2019)
  • K191795 — AOCup Lens Case with AODisc (July 31, 2019)
  • K170483 — Bausch + Lomb Sensitive Eyes Plus Saline Solution (April 11, 2017)

FDA data resources