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510(k) K221336

Device
Avéli
Applicant
Revelle Aesthetics, Inc.
510(k) number
K221336
Product code
OUP  
Decision
Substantially Equivalent (SESE)
Decision date
2022-08-05
Date received
2022-05-09
Regulation
878.4790
Classification name
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Melissa Viotti
Address
2570 W. El Camino Real, Suite 310 Mountain View CA US 94040 94040

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OUP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232153AvéliRevelle Aesthetics, Inc.2023-08-18
K212399AveliNc8, Inc.2021-10-22
K192185The Cellfina SystemUlthera, Inc.2019-10-09
K161885The Cellfina SystemUlthera, Inc.2016-10-05
K153677The Cellfina SystemUlthera, Inc.2016-02-25
K150505Cellfina SystemUlthera, Inc.2015-07-29
K134010CABOCHON SYSTEMCabochon Aesthetics, Inc.2014-04-14
DEN110004CABOCHON SYSTEMCabochon Aesthetics, Inc.2013-07-12

Legacy Summary#

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FDA Review#

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