Cleared Traditional

K220970 - Renuvion APR Handpiece

K220970 is an FDA 510(k) clearance for Renuvion APR Handpiece, manufactured by Apyx Medical Corporation(Formerly Bovie Medical Corporation). The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K220970 · Apyx Medical Corporation(Formerly Bovie Medical Corporation) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
102d
Days
Class 2
Risk

K220970 is an FDA 510(k) clearance for the Renuvion APR Handpiece. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Apyx Medical Corporation(Formerly Bovie Medical Corporation) (Clearwater, US). The FDA issued a Cleared decision on July 15, 2022 after a review of 102 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Apyx Medical Corporation(Formerly Bovie Medical Corporation) devices

FDA 510(k) Submission Details - K220970

510(k) Number K220970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2022
Decision Date July 15, 2022
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 115d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04146467 Completed Interventional Industry-sponsored

Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region

A Prospective, Multi-Center, 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

82
Patients (actual)
6
Sites
Treatment
Purpose
Open label
Masking
Condition studied Lax Skin
Study design Sequential
Eligibility All sexes · 35 Years+ · Healthy volunteers accepted
Principal investigator Paul G Ruff IV, MD
Sponsor Apyx Medical (industry)
Started 2019-11-26 → Primary completion 2022-02-28
Primary outcome
Day 180 Number of Participants With Improvement Measured By Independent Photographic Review
View full study on ClinicalTrials.gov

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1266
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