Your Choice Multi-Purpose Contact Lens Cleaning Solution
FDA 510(k) K980147 · Automatic Liquid Packaging, Inc.
510(k) numberK980147
Submission
- Device name
- Your Choice Multi-Purpose Contact Lens Cleaning Solution
- Applicant
- Automatic Liquid Packaging, Inc.
Chicago, IL, US - Received
- January 15, 1998
- Decision date
- April 13, 1998
- 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
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| 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 |
|---|---|---|
| K994321 | Sterile Water and 0.9% Sodium Chloride for Irrigation, UspJOL · Traditional | 10/25/2000SE |
| K000964 | Sterile Water or O.9% Sodium Chloride, Model AL4100 & AL4109JOH · Special | 04/25/2000SE |
| K973829 | Irrigation BottleJOH · Traditional | 02/23/1998SE |
| K962079 | Humidifier AdapterBTT · Traditional | 07/31/1996SE |
| K955104 | High Flow Adjustable Entrainment NebulizerCAF · Traditional | 06/11/1996SE |
| K920306 | Opti-Mol Filtered Puncture PinBTT · Traditional | 04/06/1992SE |
| K911770 | Optimol Respiratory Humidification SystemBTT · Traditional | 10/15/1991SE |
| K901762 | Prefilled Flexible R.T. Containers W/Ster. SodiumBTT · Traditional | 07/17/1990SE |
| K901362 | Accessory Fitment to Nebulizer System, SterileCAF · Traditional | 06/06/1990SE |
| K901301 | Ster Inhal Solut Prefil BTL W/Adjust Entrain NebulCAF · Traditional | 05/31/1990SE |
Questions and answers
When was Your Choice Multi-Purpose Contact Lens Cleaning Solution cleared by the FDA?
Your Choice Multi-Purpose Contact Lens Cleaning Solution (K980147) received a 510(k) decision of Substantially Equivalent on April 13, 1998, 88 days after the submission was received.
What is the product code of K980147?
The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.