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510(k) Data Aggregation
K Number
K231997Device Name
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
Manufacturer
Cure Point Therapeutics, Inc.
Date Cleared
2024-10-15
(468 days)
Product Code
ILY, PDZ
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
Cure Point Therapeutics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Product Code ILY - 810 and 980 nm wavelength:
The SIRONA 100 Therapy Laser System emits energy in the visible and near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle.
Product Code PDZ - 980 nm wavelength:
The SIRONA 100 Therapy Laser System is also indicated for use for the temporary increase of clear nail in patients with onychomycosis including dermatophyton rubrum and T. mentagrophytes, and/ or yeasts Candida albicans, etc.
Device Description
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