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510(k) K212331

BodySculp by Rohrer Aesthetics, LLC — Product Code PKT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2021
Date Received
July 27, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Device Class
Class II
Regulation Number
878.5400
Review Panel
SU
Submission Type

Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.

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