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510(k) K001508

LASERSKIN DRESSING by Fidia Advanced Biopolymers Srl — Product Code MGP

K001508 is an FDA 510(k) premarket notification submitted by Fidia Advanced Biopolymers Srl for the device "LASERSKIN DRESSING". The FDA issued a decision of Substantially Equivalent on July 25, 2001. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), 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
July 25, 2001
Date Received
May 15, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Occlusive
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Fidia Advanced Biopolymers Srl

  • K092257 — JALOSKIN (January 26, 2010)
  • K073251 — HYALOMATRIX PA (December 14, 2007)
  • K003855 — HYALOMATRIX CO (July 3, 2001)

Other clearances for product code MGP

  • K012995 — COLLATEK SHEET (October 25, 2001)
  • K012997 — COLLATEK FOAM (October 25, 2001)
  • K990079 — FASTSEAL CHEST WOUND DRESSING (December 23, 1999)
  • K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING (October 14, 1999)
  • K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (September 14, 1999)
  • K992005 — GILTECH PLUS TRANSPARENT DRESSING (September 3, 1999)
  • K990875 — DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (May 27, 1999)
  • K990438 — DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSI (March 25, 1999)
  • K984371 — MEPITEL NON ADHERENT SILICONE DRESSING (March 3, 1999)
  • K983303 — INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSING (December 9, 1998)

FDA data resources