Search Results
Found 1 results
510(k) Data Aggregation
K Number
K053611Device Name
SMOOTHSHAPES
Manufacturer
BICELLULASE, INC.
Date Cleared
2006-03-15
(78 days)
Product Code
NUV
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BICELLULASE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biocellulase SmoothShapes device is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local hlood circulation, and temporary reduction in the appearance of cellulite.
Device Description
The SmoothShapes system consists of a main console unit and an applied part (massage head with rollers) which is connected to the main console by an umbilical. The main console unit contains the powersupply, hardware, transformers, fuses, cooling fan, mains-input connection, and the key-switch. The massage head, which is placed against the patient's skin, contains the rollers, LEDs, and laser diodes. The massage head rollers are mobilized in rotation and sliding back and forth. The patient massage is generated by the vacuum introduced to skin fold between the two rollers. The rollers in combination with the vacuum manipulate and smooth out the skin which facilitates tissue mobilization. The laser light provides topical heating which increases tissue temperature.
Ask a Question
Page 1 of 1