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510(k) Data Aggregation
K Number
K211652Device Name
Renuvion Dermal Handpiece, Renuvion Dermal System
Manufacturer
Apyx Medical Corporation (formerly Bovie Medical Corporation
Date Cleared
2022-05-25
(362 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Apyx Medical Corporation (formerly Bovie Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Renuvion® Dermal System is an electrosurgical device for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III. The treatment is achieved through controlled heating of the outer layers of the skin so that part or all of the epidermis becomes non-viable and there is controlled thermal modification to the underlying dermis.
The Renuvion® Dermal Handpiece is only compatible with Apyx Medical Electrosurgical Generators.
Device Description
The Renuvion® Dermal Handpiece is a sterile single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible Apyx Helium Plasma Generator (APYX-200P, APYX-RS3 - cleared under 510(k) K170188 & K192867) for the delivery of radiofrequency energy and/or helium plasma for the delivery of helium plasma for the noninvasive treatment of facial wrinkles and rhytides, in patients with Fitzpatrick skin types I, II or III.
The Renuvion Dermal handpiece is part of the Renuvion System composed of the compatible Apyx generator, Foot switch, helium source, and patient grounding pad.
The tip of the Renuvion® Dermal Handpiece is used to deliver thermal energy to tissue through a precise helium plasma beam. The device connects to the electrosurgical generator which is also connected to a helium gas tank and regulator. The device requires the use of a grounding pad plugged into the generator to complete the circuit. The device is offered only in one size, 44mm, catalog number APYX-044-DERM. The handpiece is activated by pressing the activation button on the handpiece or by pressing the purple foot pedal on the foot control accessory. The device is rated at 4.0kVpeak.
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K Number
K202880Device Name
J-Plasma Precise FLEX Handpiece
Manufacturer
Apyx Medical Corporation (formerly Bovie Medical Corporation
Date Cleared
2021-01-04
(98 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Apyx Medical Corporation (formerly Bovie Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The J-Plasma Precise® FLEX is used for the delivery of radiofrequency energy and/or helium gas plasma (J-Plasma energy) for electrosurgical cutting, coagulation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures.
The J-Plasma Precise® FLEX is compatible with Apyx Medical electrosurgical generators.
Device Description
The J-Plasma Precise® Flex Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the delivery of radiofrequency ("RF") energy and/or helium gas plasma for electrosurgical cutting, coaqulation, and ablation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures. The handpiece has one configuration, model # APYX-500BF. The compatible Generators operate at an adjustable power of up to 40 W (expressed as 0-100% where 100% is 40 W) and provide an adjustable helium gas flow of 1-5 LPM. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation.
The J-Plasma Precise® Flex Handpiece has an extendable electrode (blade) in the tip to generate helium plasma. The tip is controlled by the user via graspers to actuate (extend and retract) the blade. The handpiece comes with an Introducer that allows for more control of the tip when introducing and removing the distal end to and from the cannula. The handpiece has a flexible, seamless cable that can be advanced with graspers through the cannula during minimally invasive surgical procedures. The handpiece is activated by the footswitch.
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