Ceramax Skin Barrier Cream
FDA 510(k) K152055 · Oculus Innovative Sciences
510(k) numberK152055
Submission
- Device name
- Ceramax Skin Barrier Cream
- Applicant
- Oculus Innovative Sciences
Petaluma, CA, US - Received
- July 24, 2015
- Decision date
- November 23, 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254041 | SkinSmart Antimicrobial HydroGelFRO · Traditional | Magic Science Supply, LLC | 09/11/2026SE |
| K261646 | Redermax® Antibacterial Wound MatrixFRO · Traditional | Beijing Kreate Medical Co., Ltd. | 08/14/2026SE |
| K253665 | Vashe Plus Antimicrobial SolutionFRO · Traditional | Urgo Medical North America, LLC | 08/11/2026SE |
| K261023 | Microdacyn Wound Irrigation SolutionFRO · Traditional | Sonoma Pharmaceuticals, Inc. | 06/24/2026SE |
| K251929 | SilverCeuticals® Antimicrobial Wound GelFRO · Traditional | Silverceuticals, Inc. | 06/24/2026SE |
| K261638 | Bonvadis®FRO · Special | Oneness Biotech Co., Ltd. | 06/17/2026SE |
| K254073 | StatSeal DiscFRO · Traditional | Merit Medical Systems, Inc. | 05/13/2026SE |
| K254191 | IWD-GelFRO · Traditional | InnovaCorium, Inc. | 04/07/2026SE |
| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
| K251999 | Promogran Prisma Collagen Matrix with ORC and SilverFRO · Traditional | Solventum Germany GmbH | 03/13/2026SE |
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 |
| K152945 | Alevicyn SG Antipruritic GelFRO · Traditional | 12/15/2015SE |
| 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 Ceramax Skin Barrier Cream cleared by the FDA?
Ceramax Skin Barrier Cream (K152055) received a 510(k) decision of Substantially Equivalent on November 23, 2015, 122 days after the submission was received.
What is the product code of K152055?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.