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510(k) K120938

THE PL-1064 LASER SYSTEM by Sheaumann Laser, Inc. — Product Code PDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2012
Date Received
March 22, 2012
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.).

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