Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Apyx Medical medical devices: approvals, recalls and adverse events

Stock: APYX. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

De Novo: 0

PMA approvals

0 supplements

Recalled products

0 class I

Adverse event reports

537

2 deaths reported

How many recalls does Apyx Medical have?

Apyx Medical has 15 recalled medical device products in 5 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Feb 1, 2021. In 2020 it had 2 recalled products.

How many medical devices has Apyx Medical had cleared or approved?

36 510(k) clearances, 0 De Novo grants and 0 original PMA approvals for high-risk devices, plus 0 PMA supplements (changes to approved devices). The newest decision was on Aug 21, 2026.

How many adverse event reports name Apyx Medical devices?

537 reports in total: 2 deaths, 266 injuries and 237 malfunctions were reported. 53 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	2	0	0	0
2025	1	0	0	0
2023	3	0	0	0
2022

Newest clearances and approvals

AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors
K261710 · 510(k) clearance · Aug 21, 2026
AYON Body Contouring System (AYON SYSTEM)
K253396 · 510(k) clearance · May 8, 2026
AYON Body Contouring System (AYON SYSTEM)
K244050 · 510(k) clearance · May 12, 2025
Renuvion® Micro Handpiece
K230586 · 510(k) clearance · Jun 9, 2023
Renuvion® APR Handpiece
K230272 · 510(k) clearance · Apr 27, 2023
Renuvion® APR Handpiece
K223262 · 510(k) clearance · Feb 23, 2023
Apyx One Console
K221830 · 510(k) clearance · Oct 11, 2022
Renuvion APR Handpiece
K220970 · 510(k) clearance · Jul 15, 2022
Renuvion Dermal Handpiece, Renuvion Dermal System
K211652 · 510(k) clearance · May 25, 2022
J-Plasma Precise FLEX Handpiece
K202880 · 510(k) clearance · Jan 4, 2021
Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)
K192867 · 510(k) clearance · Oct 31, 2019
Apyx Plasma/RF Handpiece

Devices with the most adverse event reports

By product code, all years

Electrosurgical, Cutting & Coagulation & Accessories (GEI, class 2)467
Unit, Cautery, Thermal, Battery-Powered (HQP, class 2)54
Electrocautery, Gynecologic (And Accessories) (HGI, class 2)10
Apparatus, Exhaust, Surgical (FYD, class 2)1
System, Suction, Lipoplasty For Removal (QPB, class 2)1
Automated External Defibrillators (Non-Wearable) (MKJ, class 3)1
Burr, Corneal, Battery-Powered (HOG, class 1)1
Stimulator, Nerve (ETN, class 2)1
Arthroscope (HRX, class 2)1

All device makers and procedures · APYX stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to APYX with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Reports	Deaths
2026	0	4	-
2025	0	53	-
2024	0	60	-
2023	0	64	1
2022	0	83	-
2021	3	43	1
2020	2	42	-
2019	0	35	-
2018	6	50	-
2017	0	11	-
2016	4	12	-
2015	0	8	-
2014	0	2	-
2013	0	10	-
2012	0	22	-

Newest recalls

ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during art
Class II · Feb 1, 2021 · There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current packa
HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthro
Class II · Feb 1, 2021 · There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current packa
Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during a
Class II · Feb 1, 2021 · There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current packa
Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B
Class II · Apr 20, 2020 · Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, a
Class II · Apr 20, 2020 · Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cut
Class II · Jun 18, 2018 · There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue.
J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS
Class II · Feb 8, 2018 · Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an inco
J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B
Class II · Feb 8, 2018 · Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an inco
J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF
Class II · Feb 8, 2018 · Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an inco
J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR
Class II · Feb 8, 2018 · Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an inco