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
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
| 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