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
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
| 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
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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