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510(k) K130805

MENICON UNIQUE PH MULTI-PURPOSE SOLUTION by Menicon Co, Ltd. — Product Code MRC

K130805 is an FDA 510(k) premarket notification submitted by Menicon Co, Ltd. for the device "MENICON UNIQUE PH MULTI-PURPOSE SOLUTION". The FDA issued a decision of Substantially Equivalent on July 3, 2013. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918. Menicon Co, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2013
Date Received
March 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Device Class
Class II
Regulation Number
886.5918
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)
  • 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)
  • K082855 — MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES (March 9, 2010)

Other clearances for product code MRC

  • K251876 — cleadew GP hydra one (October 9, 2025)
  • K200416 — Boston One Step Liquid Enzymatic Cleaner (September 23, 2020)
  • K201069 — VibrantVue Scleral Saline (July 31, 2020)
  • K182984 — MaxiTears Contacts PF (July 24, 2019)
  • K181566 — Nutrifill (October 22, 2018)
  • K181627 — Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step (August 10, 2018)
  • K180319 — Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning (March 27, 2018)
  • K173089 — Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditionin (November 27, 2017)
  • K173136 — Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses (November 16, 2017)
  • K122273 — MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS (January 2, 2013)

FDA data resources