Alcon Multi-Pirpose Disinfecting Solution
FDA 510(k) K102860 · Alcon Research, Ltd.
510(k) numberK102860
Submission
- Device name
- Alcon Multi-Pirpose Disinfecting Solution
- Applicant
- Alcon Research, Ltd.
Fort Worth, TX, US - Received
- September 30, 2010
- Decision date
- May 10, 2011
- 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 |
|---|---|---|
| K191650 | LEGION SystemHQC · Traditional | 11/01/2019SE |
| K161794 | CENTURION Vision System (Active SentryTM)HQC · Traditional | 04/14/2017SE |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy…MLZ · Special | 03/22/2017SE |
| K141065 | Constellation Vision SystemHQE · Traditional | 08/22/2014SE |
| K121031 | Wavelight FS200 Patient Interface 1505GEX · Abbreviated | 06/21/2012SE |
| K112977 | Monarch III Iol Delivery System, Monarch III C Cartridge, Monarch III Handpiece (H4)MSS · Abbreviated | 03/27/2012SE |
| K110951 | 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…HQB · Traditional | 10/17/2011SE |
| K110166 | Clearcut S Safety KnifeHNN · Abbreviated | 05/20/2011SE |
| K101006 | Wavelight FS200 Laser System Model: FS200GEX · Traditional | 10/21/2010SE |
| K093305 | Enhanced Ultra Vit ProbeMLZ · Traditional | 04/02/2010SE |
Questions and answers
When was Alcon Multi-Pirpose Disinfecting Solution cleared by the FDA?
Alcon Multi-Pirpose Disinfecting Solution (K102860) received a 510(k) decision of Substantially Equivalent on May 10, 2011, 222 days after the submission was received.
What is the product code of K102860?
The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.