Alcon Multi-Purpose Disinfecting Solution
FDA 510(k) K050729 · Alcon Research, Ltd.
510(k) numberK050729
Submission
- Device name
- Alcon Multi-Purpose Disinfecting Solution
- Applicant
- Alcon Research, Ltd.
Fort Worth, TX, US - Received
- March 21, 2005
- Decision date
- September 14, 2005
- 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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| 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 |
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| 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 |
| K102860 | Alcon Multi-Pirpose Disinfecting SolutionLPN · Traditional | 05/10/2011SE |
| K101006 | Wavelight FS200 Laser System Model: FS200GEX · Traditional | 10/21/2010SE |
Questions and answers
When was Alcon Multi-Purpose Disinfecting Solution cleared by the FDA?
Alcon Multi-Purpose Disinfecting Solution (K050729) received a 510(k) decision of Substantially Equivalent on September 14, 2005, 177 days after the submission was received.
What is the product code of K050729?
The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.