FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICROCYN SCAR MANAGEMENT HYDROGEL
K Number: K131672
·
Decision Nov 15, 2013
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
0
Applicant Total
9
Review Days
162
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Basic Information
- Device Name
- MICROCYN SCAR MANAGEMENT HYDROGEL
- K Number
- K131672
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4025
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Oculus Innovative Sciences
- Date Received
- June 6, 2013
- Decision Date
- November 15, 2013
- Product Code
- PFP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PFP | Silicone Hydrogel For Scar Management | FDA class 1 | General, Plastic Surgery |
Other Clearances by Oculus Innovative Sciences
| K Number | Device Name | ||
|---|---|---|---|
| K162217 | LOYON | Mar 23, 2017 | Substantially Equivalent |
| K161034 | Microcyn Plus Wound Care Solution | Aug 19, 2016 | Substantially Equivalent |
| K153648 | Microcyn Plus Skin and Wound Hydrogel | Apr 19, 2016 | Substantially Equivalent |
| K152945 | Alevicyn SG Antipruritic Gel | Dec 15, 2015 | Substantially Equivalent |
| K152055 | Ceramax Skin Barrier Cream | Nov 23, 2015 | Substantially Equivalent |
| K143590 | Alevicyn SG Antipruritic Gel | Jun 4, 2015 | Substantially Equivalent |
| K141352 | ENDOCYN ROOT CANAL IRRIGATION SOLUTION | Aug 18, 2014 | Substantially Equivalent |
| K141012 | HYDROCLEANSE WOUND CARE SOLUTION | Aug 8, 2014 | Substantially Equivalent |