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510(k) K061603

SMOOTHSHAPES by Biocellulase, Inc. — Product Code NUV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2006
Date Received
June 8, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Vacuum, Light Induced Heating
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

The device is intended to temporarily alter the appearance of cellulite

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