Triworks ETERNA

by Triworks Group Srl

Triworks ETERNA is a Class II device made by Triworks Group Srl, cleared under FDA 510(k) K192621 on 6 Nov 2020 and listed in FDA GUDID since 29 Feb 2024 (UDI-DI 08057168020014), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08057168020014 UDI-DI	Date29 Feb 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK192621	Date6 Nov 2020Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08057168020014
FDA 510(k) database 510(k) number K192621

Across registries

2 registries list this device

FDA 510(k) K192621 decided 6 Nov 2020 Active
FDA GUDID UDI-DI 08057168020014 listed 29 Feb 2024 Listed

Timeline

2 dated events

6 Nov 2020 Cleared FDA 510(k) K192621
29 Feb 2024 Listed FDA GUDID 08057168020014

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Triworks
Generic name: Radio-frequency skin/body contouring system
Model / reference: ETERNA

Primary DI / UDI-DI: 08057168020014
510(k) Number: K192621
FDA product code: GEI
GMDN term: Radio-frequency skin/body contouring system

Device class: Class II
Regulation number: 878.4400
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Radio-frequency skin/body contouring system.

Other devices from Triworks Group Srl

See all devices from Triworks Group Srl →

Properties

Serial number
Manufacturing date

Other properties (13, all answered No)