Menicon Unique PH Multi-Purpose Solution
FDA 510(k) K130805 · Menicon Co, Ltd.
510(k) numberK130805
Submission
- Device name
- Menicon Unique PH Multi-Purpose Solution
- Applicant
- Menicon Co, Ltd.
Wilmington, MA, US - Received
- March 25, 2013
- Decision date
- July 3, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRC – Products, Contact Lens Care, Rigid Gas Permeable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5918
- Specialty
- Ophthalmic
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| K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensesMRC · Traditional | Menicon Co, Ltd. | 11/16/2017SE |
| K122273 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensMRC · Abbreviated | Menicon Co, Ltd. | 01/02/2013SE |
More from Menicon Co, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionLPN · Traditional | 08/13/2026SE |
| K193399 | Miru 1day UpSide (midafilcon A)LPL · Traditional | 06/17/2020SE |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionLPN · Traditional | 03/02/2020SE |
| K180819 | One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensLPL · Traditional | 05/16/2018SE |
| K180004 | Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact LensLPL · Traditional | 02/22/2018SE |
| K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensesMRC · Traditional | 11/16/2017SE |
| K151768 | Menicon Saline Rinse SolutionLPN · Traditional | 08/28/2015SE |
| K122273 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensMRC · Abbreviated | 01/02/2013SE |
| K102895 | One Day Flat PackLPL · Traditional | 04/28/2011SE |
| K103561 | Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact LensHQD · Traditional | 02/03/2011SE |
Questions and answers
When was Menicon Unique PH Multi-Purpose Solution cleared by the FDA?
Menicon Unique PH Multi-Purpose Solution (K130805) received a 510(k) decision of Substantially Equivalent on July 3, 2013, 100 days after the submission was received.
What is the product code of K130805?
The FDA product code is MRC – Products, Contact Lens Care, Rigid Gas Permeable, a Class II (moderate risk) device regulated under 21 CFR 886.5918.