510(k) K171242

Alma LipoFlow System by Alma Lasers, Inc. — Product Code MUU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 14, 2017
Date Received: April 27, 2017
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Suction, Lipoplasty
Device Class: Class II
Regulation Number: 878.5040
Review Panel: SU
Submission Type

See Federal Register Notice at 86 FR 50887 Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article (FRN) (FDA-2021-N-0881).

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