Menicon Saline Rinse Solution
FDA 510(k) K151768 · Menicon Co, Ltd.
510(k) numberK151768
Submission
- Device name
- Menicon Saline Rinse Solution
- Applicant
- Menicon Co, Ltd.
Nagoya, JP - Received
- June 30, 2015
- Decision date
- August 28, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPN – Accessories, Soft Lens Products
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5928
- Specialty
- Ophthalmic
Other 510(k)s with product code LPN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionLPN · Traditional | Menicon Co, Ltd. | 08/13/2026SE |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting DropsLPN · Traditional | Bausch & Lomb, Incorporated | 12/06/2022SE |
| K221263 | Aqua Naina Plus Sterile Saline SolutionLPN · Special | Chemtex USA, Inc. | 10/12/2022SE |
| K202932 | ABT12 multi-purpose solutionLPN · Traditional | Bausch & Lomb, Incorporated | 05/28/2021SE |
| K210051 | OTE MPS 045 Multi-purpose Lens Care SolutionLPN · Traditional | Ote North America, LLC | 05/26/2021SE |
| K193441 | Aqua Naina Sterile Saline SolutionLPN · Traditional | Chemtex USA, Inc. | 05/26/2020SE |
| K200747 | PuriLens Plus Preservative Free SalineLPN · Traditional | The Lifestyle Company, Inc. | 05/15/2020SE |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionLPN · Traditional | Menicon Co, Ltd. | 03/02/2020SE |
| K190674 | REFRESH RELIEVA For CONTACTSLPN · Traditional | Allergan, Inc. | 08/08/2019SE |
| K191795 | AOCup Lens Case with AODiscLPN · Special | Alcon Laboratories, Inc. | 07/31/2019SE |
More from Alcon Laboratories, Inc.
| 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 |
| 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 Saline Rinse Solution cleared by the FDA?
Menicon Saline Rinse Solution (K151768) received a 510(k) decision of Substantially Equivalent on August 28, 2015, 59 days after the submission was received.
What is the product code of K151768?
The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.