Home / 510(k) Clearances / K131672

510(k) K131672

MICROCYN SCAR MANAGEMENT HYDROGEL by Oculus Innovative Sciences — Product Code PFP

K131672 is an FDA 510(k) premarket notification submitted by Oculus Innovative Sciences for the device "MICROCYN SCAR MANAGEMENT HYDROGEL". The FDA issued a decision of Substantially Equivalent on November 15, 2013. The device falls under product code PFP (Silicone Hydrogel For Scar Management), a Class I device regulated under 21 CFR 878.4025. Oculus Innovative Sciences has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2013
Date Received
June 6, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Silicone Hydrogel For Scar Management
Device Class
Class I
Regulation Number
878.4025
Review Panel
SU
Submission Type

Management of closed hyperproliferative (hypertrophic and keloid) scars.

Other clearances by Oculus Innovative Sciences

  • 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)
  • K102945 — PEDIACYN ATOPIC DERMATITIS HYDROGEL (February 2, 2011)
  • K093585 — MICROCYN SKIN AND WOUND HYDROGEL (March 8, 2010)

FDA data resources