HomeUSAApyx Medical Corporation

Apyx Medical Corporation

USA · Clearwater
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
6listed device types
Class I 2Class II 4Class III 0
plus 28 registration records and 12 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
7 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States28 registration records, 12 510(k), 0 PMA, 1 excluded
Manufacturer names merged into this page: Apyx Medical Corporation · APYX MEDICAL CORPORATION

Company information

Country
USA
City
Clearwater

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
Apyx Medical Corp
CIK
0000719135
Registration status
Active
Listing status
Listed (APYX)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

32019
12021
32022 · K221830
32023 · K230586
12025 · K244050
12026 · K253396

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Unit, Cautery, Thermal, Battery-Powered 1Unit, Electrosurgical, Endoscopic (With Or Without Accessories) 1System, Suction, Lipoplasty For Removal 1Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) 1Brush, Scrub, Operating-Room 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253396AYON Body Contouring System™ (AYON SYSTEM)2026-05-08
USK244050AYON Body Contouring System (AYON SYSTEM)2025-05-12
USK230586Renuvion® Micro Handpiece2023-06-09

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