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510(k) Data Aggregation
K Number
K190034Device Name
REMY Medical Therapy Laser System
Manufacturer
Footdocprenur, LLC
Date Cleared
2019-05-15
(128 days)
Product Code
PDZ, GEX, ILY
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Footdocprenur, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The REMY device emits energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a 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.
The REMY is intended for use in Podiation, vaporization, incision, and coagulation of soft tissue) including periungual, subungual, and plantar warts.
The REMY is also indicated for use for the temporary increase of clear nail in patients with onychomycosis including dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc., and for the temporary increase of clear nail in patients with onychomycosis including dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc..
Device Description
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