Skip to content

J-Plasma® APYX-500BF

by Apyx Medical Corporation

Ref APYX-500BF

J-Plasma® APYX-500BF is a device classified as Class IIb in the EU and Class II in the US made by Apyx Medical Corporation, registered in EUDAMED on 24 Jun 2026 (Basic UDI-DI B-00607151050177), cleared under FDA 510(k) K202880 on 4 Jan 2021 and listed in FDA GUDID since 14 Jan 2021 (UDI-DI 00607151050177), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202880

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00607151050177 Basic UDI-DI 00607151050177UDI-DIDate24 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00607151050177 UDI-DI Date14 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202880 Date4 Jan 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00607151050177 registered 24 Jun 2026 Active
  • FDA 510(k) K202880 decided 4 Jan 2021 Active
  • FDA GUDID UDI-DI 00607151050177 listed 14 Jan 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K202880
  2. Listed FDA GUDID 00607151050177
  3. Registered EUDAMED B-00607151050177

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
J-Plasma Precise® FLEX 500mm EUDAMED
J-Plasma® GUDID
Generic name
Electrosurgical handpiece, single-use
Model / Ref / Catalog
APYX-500BF
Primary DI / UDI-DI
00607151050177
Basic UDI-DI
B-00607151050177
510(k) Number
FDA product code
GEI
EMDN code
K0201010501 Open electrosurgery handpieces, single-use
GMDN term
Electrosurgical handpiece, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrosurgical handpiece, single-use

Similar devices in this category

Other devices filed under OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE.

Other devices from Apyx Medical Corporation

See all devices from Apyx Medical Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)