Alcon Multi-Purpose Solution
FDA 510(k) K071236 · Alcon, Inc.
510(k) numberK071236
Submission
- Device name
- Alcon Multi-Purpose Solution
- Applicant
- Alcon, Inc.
Fort Worth, TX, US - Received
- May 3, 2007
- Decision date
- December 12, 2007
- 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 |
|---|---|---|
| K063583 | Alcon Vision SystemHQC · Traditional | 05/09/2008SE |
| K040231 | Inteliport Occluding DeviceLZU · Traditional | 07/13/2004SE |
| K031193 | Soft (Hydrophilic) Contact Lens Care SolutionLPN · Traditional | 07/03/2003SE |
| K981574 | Opti-Free Express Multi-Purpose SolutionLPN · Traditional | 07/06/1998SE |
Questions and answers
When was Alcon Multi-Purpose Solution cleared by the FDA?
Alcon Multi-Purpose Solution (K071236) received a 510(k) decision of Substantially Equivalent on December 12, 2007, 223 days after the submission was received.
What is the product code of K071236?
The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.