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FDA 510(k) Applications for Medical Device Product Code "OUP"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN110004
CABOCHON AESTHETICS, INC.
CABOCHON SYSTEM
07/12/2013
K134010
CABOCHON AESTHETICS, INC.
CABOCHON SYSTEM
04/14/2014
K212399
NC8, Inc.
Aveli
10/22/2021
K232153
Revelle Aesthetics, Inc.
AvΘli
08/18/2023
K221336
Revelle Aesthetics, Inc.
AvΘli
08/05/2022
K192185
Ulthera, Inc
The Cellfina System
10/09/2019
K150505
ULTHERA, INC.
Cellfina System
07/29/2015
K153677
ULTHERA, INC.
The Cellfina System
02/25/2016
K161885
ULTHERA, INC.
The Cellfina System
10/05/2016
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