Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
FDA 510(k) K173136 · Menicon Co, Ltd.
510(k) numberK173136
Submission
- Device name
- Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
- Applicant
- Menicon Co, Ltd.
Nagoya, JP - Received
- September 29, 2017
- Decision date
- November 16, 2017
- 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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| K122273 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensMRC · Abbreviated | Menicon Co, Ltd. | 01/02/2013SE |
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| 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 |
| K151768 | Menicon Saline Rinse SolutionLPN · Traditional | 08/28/2015SE |
| K130805 | Menicon Unique PH Multi-Purpose SolutionMRC · Traditional | 07/03/2013SE |
| 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 Progent Protein Remover for Rigid Gas Permeable Contact Lenses cleared by the FDA?
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses (K173136) received a 510(k) decision of Substantially Equivalent on November 16, 2017, 48 days after the submission was received.
What is the product code of K173136?
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.