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510(k) K060113

DERMACYN WOUND CARE by Oculus Innovative Sciences, Inc. — Product Code FRO

K060113 is an FDA 510(k) premarket notification submitted by Oculus Innovative Sciences, Inc. for the device "DERMACYN WOUND CARE". The FDA issued a decision of Substantially Equivalent on February 22, 2006. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Oculus Innovative Sciences, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2006
Date Received
January 17, 2006
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, Inc.

  • 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)

Other clearances for product code FRO

  • 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)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources