Search Results
Found 2 results
510(k) Data Aggregation
K Number
K232153Device Name
Avéli
Manufacturer
Revelle Aesthetics, Inc.
Date Cleared
2023-08-18
(30 days)
Product Code
OUP, FTD, GDI
Regulation Number
878.4790Why did this record match?
Applicant Name (Manufacturer) :
Revelle Aesthetics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aveli is indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas as supported by clinical data demonstrating treatment benefits through one year of observation. Avéli is also indicated for soft tissue dissection during general and plastic surgical procedures.
Device Description
Avéli is a sterile, single-use manual instrument that releases fibrous tissue (septa) beneath cellulite for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. Avéli also dissects soft tissue in general and plastic surgical procedures. The device consists of a Handle and a Distal End. The Handle houses components used to actuate the moving parts at the distal end of the device. The Distal End is advanced into subcutaneous tissue through a small incision to a procedure location. An integrated light source provides illumination and allows the user to track and advance to the procedure location. The Distal End contains a Blade and a Blocker forming a Hook. When the Handle is moved in a retrograde fashion, the Hook captures the nearby septa or other soft tissue resulting in tugging. The user feels the resistance, confirming that septa under a cellulite depression or other treatment area have been identified and then exposes the Blade at the Distal End. The user pushes the skin distally with the free hand while maintaining the device stable or applies additional retrograde motion with the device to release the soft tissue. The user then retracts the Blocker into the device, allowing removal without further tissue engagement. The user can verify all appropriate soft tissue has been released by passing through the area again with the Hook. The step is repeated for each visible cellulite depression or other surgical area.
Ask a Question
K Number
K221336Device Name
Avéli
Manufacturer
Revelle Aesthetics, Inc.
Date Cleared
2022-08-05
(88 days)
Product Code
OUP
Regulation Number
878.4790Why did this record match?
Applicant Name (Manufacturer) :
Revelle Aesthetics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Avéli is indicated for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating treatment benefits through one year of observation.
Device Description
Avéli is a sterile, single-use manual instrument that releases fibrous tissue (septa) beneath cellulite for long-term reduction in the appearance of cellulite in the buttocks and thigh areas of adult females. The device consists of a Handle and a Distal End. The Handle houses components used to actuate the moving parts at the distal end of the device. The Distal End is advanced into subcutaneous tissue through a small incision to a procedure location. An integrated light source provides illumination and allows the user to track and advance to the procedure location. The Distal End contains a Blocker forming a Hook. When the Handle is moved in a retrograde fashion, the Hook next to fibrous septa captures the septa resulting in tugging. The user feels the resistance, confirming that septa under a cellulite depression have been identified and then exposes the Blade at the Distal End. The user pushes the skin distally with the free hand while maintaining the device stable or applies additional retrograde motion with the device to release the fibrous septa. The user then retracts the Blocker into the device, allowing removal without further tissue engagement. The user can verify all contributing septa have been released by passing through the area again with the Hook. The step is repeated for each visible cellulite depression.
Ask a Question
Page 1 of 1