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510(k) K153648

Microcyn Plus Skin and Wound Hydrogel by Oculus Innovative Sciences — Product Code FRO

K153648 is an FDA 510(k) premarket notification submitted by Oculus Innovative Sciences for the device "Microcyn Plus Skin and Wound Hydrogel". The FDA issued a decision of Substantially Equivalent on April 19, 2016. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Oculus Innovative Sciences has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2016
Date Received
December 21, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Oculus Innovative Sciences

  • K162217 — LOYON (March 23, 2017)
  • K161034 — Microcyn Plus Wound Care Solution (August 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)

Other clearances for product code FRO

  • K254041 — SkinSmart Antimicrobial HydroGel (September 11, 2026)
  • K261646 — Redermax® Antibacterial Wound Matrix (August 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (August 11, 2026)
  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)

FDA data resources