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510(k) K092257

JALOSKIN by Fidia Advanced Biopolymers Srl — Product Code FRO

K092257 is an FDA 510(k) premarket notification submitted by Fidia Advanced Biopolymers Srl for the device "JALOSKIN". The FDA issued a decision of Substantially Equivalent on January 26, 2010. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Fidia Advanced Biopolymers Srl has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2010
Date Received
July 28, 2009
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 Fidia Advanced Biopolymers Srl

  • K073251 — HYALOMATRIX PA (December 14, 2007)
  • K001508 — LASERSKIN DRESSING (July 25, 2001)
  • K003855 — HYALOMATRIX CO (July 3, 2001)

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