Oculus Innovative Sciences, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 16
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0763-2017 | Class II | Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under t | November 21, 2016 |
| Z-0890-2013 | Class II | Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, No | February 12, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K162217 | LOYON | March 23, 2017 |
| K161034 | Microcyn Plus Wound Care Solution | August 19, 2016 |
| K153648 | Microcyn Plus Skin and Wound Hydrogel | April 19, 2016 |
| K152945 | Alevicyn SG Antipruritic Gel | December 15, 2015 |
| K152055 | Ceramax Skin Barrier Cream | November 23, 2015 |
| K143590 | Alevicyn SG Antipruritic Gel | June 4, 2015 |
| K141352 | ENDOCYN ROOT CANAL IRRIGATION SOLUTION | August 18, 2014 |
| K141012 | HYDROCLEANSE WOUND CARE SOLUTION | August 8, 2014 |
| K131672 | MICROCYN SCAR MANAGEMENT HYDROGEL | November 15, 2013 |
| K102945 | PEDIACYN ATOPIC DERMATITIS HYDROGEL | February 2, 2011 |
| K093585 | MICROCYN SKIN AND WOUND HYDROGEL | March 8, 2010 |
| K090206 | OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER | June 2, 2009 |
| K090725 | OCULUS MICROCYN WOUND GEL | May 20, 2009 |
| K060113 | DERMACYN WOUND CARE | February 22, 2006 |
| K042729 | DERMACYN WOUND IRRIGATION | May 17, 2005 |
| K041161 | MICROCYN WOUND CARE DRESSING | May 3, 2005 |