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510(k) Data Aggregation
K Number
K024307Device Name
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
Manufacturer
SYBARITIC, INC.
Date Cleared
2003-07-02
(190 days)
Product Code
IMI, ISA
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
SYBARITIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for use include the following:
a. Therapeutic Massager:
i. Provides temporary relief of minor muscle aches and pains
ii. Relieves muscle spasms
iii. Temporarily improves local blood circulation
iv. Temporarily reduces the appearance of cellulite
b. Ultrasonic Diathermy :
i. Relief of pain
ii. Muscle spasms
iii. Joint contractures
iv. NOT for the treatment of malignancies
Device Description
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