Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.

The Renuvion® APR Handpiece is intended for the coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring.

The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.

The Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures.

The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical.

Device Description

The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. 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 cutting, coagulation or ablation of soft tissue during open surgical procedures. 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 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma. The handpiece is available in two different lengths: 15 cm and 27 cm. The 15 cm length is available in a single port (APYX-15-SP) as well as a twin port configuration (APYX-15-TP). The 27cm length is only available with a twin port configuration (APYX- 27-TP).

The device can also be used for percutaneous delivery of radiofrequency and helium plasma energy to coagulate subcutaneous soft tissue.

AI/ML Overview

The provided document is a 510(k) summary for the Renuvion® APR Handpiece. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. The primary change for this submission is an addition to the indications for use.

Crucially, this document describes a determination of substantial equivalence, not a study proving adherence to specific acceptance criteria for performance, particularly not for an AI/algorithm-based device as the prompt's structure implies. The device in question is an electrosurgical handpiece, a hardware device, not an AI/software device.

Therefore, many of the requested fields related to AI/algorithm performance (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable in the context of this 510(k) submission. The "Performance Data" section explicitly states "N/A" for bench testing, electrical safety, EMC, and biocompatibility because "no modifications were made to the commercially available handpiece cleared under K220970."

However, I can extract information related to the clinical justification for the expanded indications for use.

Here's an analysis based on the provided text, addressing the prompt's points where applicable, and stating "Not Applicable" or "Not Provided" where the information is not present or relevant to this type of device submission:

Device Name: Renuvion® APR Handpiece
Regulation Name: Electrosurgical cutting and coagulation device and accessories
Product Code: GEI

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit "acceptance criteria" in the format one would typically see for an AI performance study (e.g., minimum AUC, sensitivity, specificity). Instead, the assessment for substantial equivalence relies on:

Technological equivalence to predicate devices.
Demonstration of safety and effectiveness for the additional proposed indication.

The "performance" is assessed in terms of comparable safety profiles rather than specific quantitative metrics against a defined threshold.

Criterion/Characteristic	Subject Device (Renuvion® APR Handpiece - K230272)	Predicate Device (Renuvion® APR Handpiece - K220970)	Secondary Predicate Device (Renuvion® APR Handpiece - K223262)	Comments/Performance
Classification	Class II	Class II	Class II	Identical
Regulation Name & Product Code	Electrosurgical cutting & coagulation device and accessories, GEI	Electrosurgical cutting & coagulation device and accessories, GEI	Electrosurgical cutting & coagulation device and accessories, GEI	Identical
Energy Type	Helium gas plasma	Helium gas plasma	Helium gas plasma	Identical
Electrical Currents Transmitted	150mA - 250mA	150mA - 250mA	150mA - 250mA	Identical
Energy Type Delivered	Monopolar RF energy via Helium Plasma	Monopolar RF energy via Helium Plasma	Monopolar RF energy via Helium Plasma	Identical
System Components	RF Generator, Disposable HP, Foot pedal, Power cord, Gas regulator, Gas cylinder	RF Generator, Disposable HP, Foot pedal, Power cord, Gas regulator, Gas cylinder	RF Generator, Disposable HP, Foot pedal, Power cord, Gas regulator, Gas cylinder	Identical
Shaft Design & Energy Delivery Configuration	15cm and 27cm long with a side port configuration (single or twin) and indicator lines on the shaft	15cm and 27cm long with a side port configuration (single or twin) and indicator lines on the shaft	15cm and 27cm long with a side port configuration (single or twin) and indicator lines on the shaft	Identical
Shaft Outer Diameter	3mm	3mm	3mm	Identical
Electrode Configuration	Non-extendable	Non-extendable	Non-extendable	Identical
Plasma Settings	Maximum 40 watts, 1-5 L/min gas flow	Maximum 40 watts, 1-5 L/min gas flow	Maximum 40 watts, 1-5 L/min gas flow	Identical
Compatibility	Only with Electrosurgical Generators owned by Apyx Medical	Only with Electrosurgical Generators owned by Apyx Medical	Only with Electrosurgical Generators owned by Apyx Medical	Identical
New Indication Safety Assessment	No new or increased risks for Renuvion procedures following liposuction compared to liposuction alone.	N/A (did not have this expanded indication)	N/A (did not have this expanded indication)	Assessed through real-world evidence and meta-analysis.

2. Sample size used for the test set and the data provenance

Test Set (for the new indication): The document refers to "real-world evidence gathered from 6 studies in which all procedures used Renuvion APR following liposuction."
- This data set includes retrospective chart reviews in 1,184 body areas across 483 subjects.
- Data Provenance: The document does not explicitly state the country of origin for the retrospective chart reviews. It is implied to be clinical data, likely from the US, given the FDA submission.
- Retrospective or Prospective: Primarily retrospective chart reviews for the liposuction indication. There is also a mention of an IDE study (G190152, VP-1902) for the neck and submental region (which was already an indicated use for the predicate device, not new for this submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable in the context of an AI ground truth. For this device (an electrosurgical handpiece), "ground truth" relates to clinical outcomes and safety profiles, typically established by treating physicians and follow-up. The data relies on clinical records and published meta-analyses. No specific "experts" were convened to "establish ground truth" for a test set in the way one would for an AI study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This is not an AI performance study requiring image or data annotation adjudication. Clinical outcomes are typically recorded by the treating physician or study staff, and adverse events are reported as per standard clinical practice.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI device. The study described compares adverse event rates of Renuvion APR following liposuction to liposuction alone, based on a meta-analysis. It does not involve human readers interpreting images, assisted or unassisted by AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is clinical outcomes and adverse event rates derived from:
- Retrospective chart reviews (for the new liposuction-related indication).
- Data from a previously conducted IDE study (for the neck and submental region indication, which was already on the predicate).
- Comparative data from a published meta-analysis (for liposuction alone adverse event rates).

8. The sample size for the training set

Not Applicable. This is not an AI device that requires a training set. The clinical data mentioned (1,184 body areas across 483 subjects) serves as the evidence for safety and effectiveness for the new indication.

9. How the ground truth for the training set was established

Not Applicable. As this is not an AI device, there is no "training set" or "ground truth for the training set" in the context of machine learning. Clinical data collection follows established medical record-keeping and study protocols.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, while the text on the right is in blue and is arranged in three lines.

May 8, 2023

Apyx Medical Corporation Angela Huber Global Director of Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760-4004

Re: K230272

Trade/Device Name: Renuvion® APR Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI

Dear Angela Huber:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 27, 2021. Specifically, FDA is updating this SE Letter due to a formatting error in which the K-number appears as 2K230272 in the header of page 2 as an administrative correction.

Please note that the 510(k) sub mission was not re-reviewed. For questions regarding this letter please contact Long Chen, OHT4: Office of Surgical and Infection Control Devices, 301-796-6389, or Long. Chen@fda.hhs.gov.

Sincerely,

Mark Trumbore, Ph.D.

Mark Trumbore Digitally signed by Mark Trumbore -S Date: 2023.05.08 08:19:04 -04'00'

For Long Chen, Ph.D. Acting Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 27, 2023

Apyx Medical Corporation Angela Huber Global Director of Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760-4004

Re: K230272

Trade/Device Name: Renuvion® APR Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: March 31, 2023 Received: March 31, 2023

Dear Angela Huber:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{2}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.04.27 13:00:33 -04'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name Renuvion® APR Handpiece

Indications for Use (Describe)

Renuvion APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.

The Renuvion APR Handpiece is intended for the coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring.

The Renuvion APR Handpiece is indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.

The Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures.

The Renuvion APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) SUMMARY

1. General Information

Submitted by:	Apyx Medical Corporation5115 Ulmerton RoadClearwater, Florida 33760-4004United States of America
Establishment Registration #:	3007593903
Contact Person:	Angela Huber, PhD, RAC,
	Global Director of Regulatory AffairsPhone: 218-343-4881Email: angela.huber@apyxmedical.com
Date Prepared:	March 30th, 2023
Trade Name (Model Numbers):	Renuvion® APR Handpiece(APYX-15-SP, APYX-15-TP, APYX-27-TP)
Common Name:	Electrosurgical Handpiece
Classification:	Class II per 21CFR 878.4400 - ElectrosurgicalCutting and Coagulation Device andAccessoriesProduct Code GEI
Predicate Device:Secondary Predicate Device:	Renuvion® APR Handpiece (K220970)Renuvion® APR Handpiece (K223262)

2. Proposed Indications for Use

Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.

The Renuvion® APR Handpiece is intended for coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring.

The Renuvion® APR Handpiece is indicated for use in subcutaneous dermatological

{5}------------------------------------------------

and aesthetic procedures to improve the appearance of lax (loose) skin in the neck and submental region.

The Renuvion® APR Handpiece is intended for the delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures.

The Renuvion® APR Handpiece is intended to be used with compatible electrosurgical generators owned by Apyx Medical.

3. Device Description

The device can also be used for percutaneous delivery of radiofrequency and helium plasma energy to coagulate subcutaneous soft tissue. The recommended settings for subcutaneous soft tissue coagulation are provided in detail in Section C.1 RECOMMENDED SETTINGS & TREATMENT PARAMETERS of the Instructions for Use.

The Renuvion® APR System with all components and accessories is shown in the picture below.

Image /page/5/Figure/8 description: This image shows a medical device setup with several components labeled. A red helium tank is connected to a gas regulator via a valve. The setup also includes a generator, a handpiece and cable, a foot switch, and a grounding pad, all arranged on a white surface.

10-2

{6}------------------------------------------------

4. Technological Characteristics

The Renuvion APR Handpiece with its components is pictured below.

Image /page/6/Figure/3 description: The image shows a medical device with several labeled parts. The device has a long, thin "Flexible Shaft" with "Energy Exit Portals" and "Tip Distance Indicators" at the end. The device also has a "Handle" with an "Activation Button", a "Plug Connector", and a "Cable".

Plug Connector

5. Performance Data

a. Bench Testing

N/A: no modifications were made to the commercially available handpiece cleared under K220970.

b. Electrical Safety and Electromagnetic Compatibility (EMC)

N/A; no modifications were made to the commercially available handpiece cleared under K220970 or generator cleared under K192867.

c. Biocompatibility Testing

N/A; no modifications were made to the commercially available handpiece cleared under K220970.

6. Pre-Clinical & Animal Studies

No modifications were made to the commercially available handpiece cleared under K220970 and K223262. Ex vivo tissue testing that included liver, kidney, and muscle tissues to measure the coagulative effect of the device on tissue was previously provided in 510(k) submission K191542 and K223262. Apyx Medical conducted a GLP Acute Porcine Study to assess thermal effects of the subject device use in subcutaneous tissue. The data demonstrated the thermal effects of the device on subcutaneous soft tissues and was previously provided in 510(k) submission K191542 and K223262.

7. Clinical Performance

The Renuvion APR handpiece safety and effectiveness in the neck and submental region was assessed in IDE, G190152 (VP-1902, A Prospective Multi-Center,

{7}------------------------------------------------

Evaluator-Blinded Study evaluating the Safety and Effectiveness of the Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region).

Apyx analyzed real-world evidence gathered from 6 studies in which all procedures used Renuvion APR following liposuction. This data set includes retrospective chart reviews in 1,184 body areas (across 483 subjects in the following body areas: abdomen, arms, back, buttocks, breast/axilla, face, hips/flanks, legs, neck) followed by coagulation of the subcutaneous soft tissues with Renuvion following liposuction. These data were then compared to the adverse event rates for liposuction alone established in a published meta-analysis. This data supports the safe use of the device for its proposed indications for use.

8. Substantial Equivalence

The Renuvion APR handpiece is the predicate device; therefore all technological and performance characteristics are the same. The only difference is the addition to the indications for use.

Feature/Characteristic	Subject Device	Predicate Device	Secondary PredicateDevice	Comments
	Renuvion® APRHandpiece(K230272)	Renuvion®APR Handpiece(K220970)	Renuvion® APRHandpiece (K223262)
Classification	Class II	Class II	Class II	Identical
RegulationName andProduct Code:	Electrosurgical cutting &coagulation device andaccessories, GEI	Electrosurgical cutting& coagulation deviceand accessories, GEI	Electrosurgical cutting &coagulation device andaccessories, GEI	Identical
Indications forUse	Renuvion® APRHandpiece is intendedfor the delivery ofradiofrequency energyand/or helium plasmawherecoagulation/contraction of soft tissue isneeded. Soft tissueincludes subcutaneoustissue.The Renuvion® APRHandpiece is intendedfor the coagulation ofsubcutaneous soft	The Renuvion® APRHandpiece is intendedfor the delivery ofradiofrequencyenergy and/or heliumplasma for cutting,coagulation andablation of soft tissueduring open surgicalprocedures.The Renuvion® APRHandpiece isindicated for use insubcutaneousdermatological andaesthetic procedures	The Renuvion® APRHandpiece is intended forthe delivery ofradiofrequency energyand/or helium plasmawherecoagulation/contractionof soft tissue is needed.Soft tissue includessubcutaneous tissue.The Renuvion® APRHandpiece is indicatedfor use in subcutaneousdermatological andaesthetic procedures toimprove the appearanceof lax (loose) skin in the	Generally, thepredicate isindicated foruse duringopen surgicalprocedure orpercutaneousproceduresand associatedsurgicalequipment.Themodificationto theintended useis to specify
	tissues followingliposuction foraesthetic bodycontouring.The Renuvion® APRHandpiece is indicatedfor use insubcutaneousdermatological andaesthetic proceduresto improve theappearance of lax(loose) skin in theneck and submentalregion.The Renuvion®APR Handpiece isintended for thedelivery ofradiofrequencyenergy and/orhelium plasma for	to improve theappearance of lax(loose) skin in theneck and submentalregion.The Renuvion®APR Handpiece isintended to be usedwith compatibleelectrosurgicalgenerators owned byApyx Medical(specifically BVX-200H, BVX-200P,APYX-200H,APYX-200P, APYX-RS3, and APYX-JS3).	neck and submentalregion.The Renuvion® APRHandpiece is intended tobe used with compatibleelectrosurgical generatorsowned by Apyx Medical.	that thehandpiece isintended forthecoagulation ofsubcutaneoussoft tissuesfollowingliposuction foraesthetic bodycontouring.
	cutting, coagulationand ablation of softtissue during opensurgical procedures.The Renuvion® APRHandpiece isintended to be usedwith compatibleelectrosurgicalgenerators owned byApyx Medical.
Energy Type	Helium gas plasma	Helium gas plasma	Helium gas plasma	Identical
ElectricalCurrentsTransmitted	150mA - 250mA	150mA - 250mA	150mA - 250mA	Identical
EnergyTypeDelivered	Monopolar RF energyvia Helium Plasma(helium facilitates theuse of low	Monopolar RF energyvia Helium Plasma(helium facilitates theuse of low	Monopolar RF energyvia Helium Plasma(helium facilitates theuse of low	Identical
SystemComponents	The ApyxPlasma/RFSystem consists of:- RF Generator- Disposable HP- Foot pedal- Power cord- Gas regulator- Gas cylinder	The ApyxPlasma/RFSystem consists of:- RF Generator- Disposable HP- Foot pedal- Power cord- Gas regulator- Gas cylinder	The ApyxPlasma/RFSystem consists of:- RF Generator- Disposable HP- Foot pedal- Power cord- Gas regulator- Gas cylinder	Identical
User Interface	Straight	Straight	Straight	Identical
Shaft Design &Energy DeliveryConfiguration	15cm and 27cm longwith a side portconfiguration (singleor twin) andindicator lines on theshaft	15cm and 27cm longwith a side portconfiguration (singleor twin) andindicator lines on theshaft	15cm and 27cm longwith a side portconfiguration (singleor twin) andindicator lines on theshaft	Identical
Shaft OuterDiameter	3mm	3mm	3mm	Identical
ElectrodeConfiguration	Non-extendable	Non-extendable	Non-extendable	Identical
Plasma Settings	Maximum 40 watts,1-5L/min gas flow	Maximum 40 watts,1-5L/min gas flow	Maximum 40 watts,1-5L/min gas flow	Identical
Compatibility	Only withElectrosurgicalGenerators owned byApyx Medical	Only withElectrosurgicalGenerators owned byApyx Medical	Only withElectrosurgicalGenerators owned byApyx Medical	Identical

{8}------------------------------------------------

{9}------------------------------------------------

9. Substantial Equivalence Determination

The subject device and predicate device are identical with the exception of the modification to the intended use statement to specify that the Renuvion® APR Handpiece is intended for the coagulation of subcutaneous soft tissues following liposuction for aesthetic body contouring. Apyx was able to assess the device based on a large set of retrospective chart reviews.

No new risks were identified in the risk analysis or real-world evidence and published literature analysis. Renuvion treatment adverse events (AEs) compared to the realworld evidence gathered for the liposuction treatments in the literature review demonstrated there are no new or increased risks for Renuvion procedures following liposuction procedures compared to liposuction alone. These findings support the proposed indications for use.

{10}------------------------------------------------

10. Conclusion

The Renuvion APR is identical in terms of principle of operation, mechanism of action and sterilization methods to the predicate device, Renuvion APR (K220970 and K223262). The only difference between the subject and predicate devices is the indications for use statement. The clinical data presented in this 510(k) supports the substantial equivalence of safety and effectiveness of the subject device for the proposed indications for use. Therefore, the subject device is as safe and effective as the predicate, and the data presented supports a substantially equivalent decision.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.