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510(k) K152945

Alevicyn SG Antipruritic Gel by Oculus Innovative Sciences — Product Code FRO

K152945 is an FDA 510(k) premarket notification submitted by Oculus Innovative Sciences for the device "Alevicyn SG Antipruritic Gel". The FDA issued a decision of Substantially Equivalent on December 15, 2015. 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
December 15, 2015
Date Received
October 6, 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)
  • K153648 — Microcyn Plus Skin and Wound Hydrogel (April 19, 2016)
  • 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

  • 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