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510(k) K110375

BLUESHINE'S GOLD SERIES by Blueshine Srl — Product Code PDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2012
Date Received
February 9, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).

Other clearances by Blueshine Srl

  • K090297 — BLUESHINE GOLD SERIES (April 14, 2009)
  • K063060 — BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP (November 29, 2006)

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