Cleared Traditional

K211652 - Renuvion Dermal Handpiece

K211652 is an FDA 510(k) clearance for Renuvion Dermal 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 362-day FDA review.

K211652 · Apyx Medical Corporation(Formerly Bovie Medical Corporation) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
362d
Days
Class 2
Risk

K211652 is an FDA 510(k) clearance for the Renuvion Dermal Handpiece, Renuvion Dermal System. 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 May 25, 2022 after a review of 362 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K211652

510(k) Number K211652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2021
Decision Date May 25, 2022
Days to Decision 362 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
247d slower than avg
Panel avg: 115d · This submission: 362d
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
NCT03286283 Completed Interventional Industry-sponsored

The Use of J-Plasma® for Dermal Resurfacing

A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of J-Plasma® for Dermal Resurfacing

55
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Facial Wrinkles; Rhytides
Study design Single group
Eligibility All sexes · 30 Years+
Principal investigator Cindy Ponce, BS(ACS)
Sponsor Apyx Medical (industry)
Started 2018-01-22 → Primary completion 2018-08-20 → Completed 2018-11-16
Primary outcome
Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score
Secondary outcome
Number of Participants With a ≥ 1-score Improvement on the Fitzpatrick Wrinkle and Elastosis Scale (FWS) and at Least an "Improved" Rating on the Modified Global Aesthetic Improvement Scale (GAIS) at the 3-month Visit.
View full study on ClinicalTrials.gov

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1266
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K211652.
SYLFIRM X
K213612 · VIOL Co., Ltd. · Jun 2022
ACUTRON
K211000 · Ilooda Co,., Ltd. · Jun 2022
SILKRO
K210084 · Hironic Co., Ltd. · Jun 2022
Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
K220481 · Stryker Sustainability Solutions · May 2022
Plasmage System
K202106 · Brera Medical, Inc. · Apr 2022
PLEXR PLUS
K210693 · Gmv S.R.L. · Mar 2022