Alevicyn SG Antipruritic Gel
FDA 510(k) K152945 · Oculus Innovative Sciences
510(k) numberK152945
Submission
- Device name
- Alevicyn SG Antipruritic Gel
- Applicant
- Oculus Innovative Sciences
Petaluma, CA, US - Received
- October 6, 2015
- Decision date
- December 15, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
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More from Solventum Germany GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K162217 | LoyonFRO · Traditional | 03/23/2017SE |
| K161034 | Microcyn Plus Wound Care SolutionFRO · Traditional | 08/19/2016SE |
| K153648 | Microcyn Plus Skin and Wound HydrogelFRO · Traditional | 04/19/2016SE |
| K152055 | Ceramax Skin Barrier CreamFRO · Traditional | 11/23/2015SE |
| K143590 | Alevicyn SG Antipruritic GelFRO · Traditional | 06/04/2015SE |
| K141352 | Endocyn Root Canal Irrigation SolutionKJJ · Traditional | 08/18/2014SE |
| K141012 | Hydrocleanse Wound Care SolutionFRO · Traditional | 08/08/2014SE |
| K131672 | Microcyn Scar Management HydrogelPFP · Traditional | 11/15/2013SE |
| K102945 | Pediacyn Atopic Dermatitis HydrogelFRO · Traditional | 02/02/2011SE |
| K093585 | Microcyn Skin and Wound HydrogelFRO · Traditional | 03/08/2010SE |
Questions and answers
When was Alevicyn SG Antipruritic Gel cleared by the FDA?
Alevicyn SG Antipruritic Gel (K152945) received a 510(k) decision of Substantially Equivalent on December 15, 2015, 70 days after the submission was received.
What is the product code of K152945?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.