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510(k) Data Aggregation
K Number
K150138Device Name
Aspen Laser Systems Therapy Laser System
Manufacturer
ASPEN LASER SYSTEMS, LLC
Date Cleared
2015-05-08
(106 days)
Product Code
PDZ, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ASPEN LASER SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including: Matrixectomy, periungual and subungual warts, neuromas, and plantar warts. The VelasII is also indicated for use 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.).
Device Description
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K Number
K142078Device Name
VELASII THERAPY LASER SYSTEM
Manufacturer
ASPEN LASER SYSTEMS, LLC
Date Cleared
2014-10-30
(91 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
ASPEN LASER SYSTEMS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VelasII Therapy Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
Device Description
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