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AYON Console AYON-CONSOLE

by Apyx Medical Corporation

AYON Console AYON-CONSOLE is a Class II device made by Apyx Medical Corporation, cleared under FDA 510(k) K244050 on 12 May 2025 and listed in FDA GUDID since 3 Jun 2025 (UDI-DI 00607151050504), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K244050

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00607151050504 UDI-DI Date3 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK244050 Date12 May 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K244050 decided 12 May 2025 Active
  • FDA GUDID UDI-DI 00607151050504 listed 3 Jun 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K244050
  2. Listed FDA GUDID 00607151050504

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AYON Console
Generic name
Liposuction system
Model / reference
AYON-CONSOLE
Primary DI / UDI-DI
00607151050504
510(k) Number
FDA product code
QPB
GMDN term
Liposuction system
Device class
Class II
Regulation number
878.5040
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)