Twain Evo OAM002017

by Quanta System SpA

Twain Evo OAM002017 is a Class II device made by Quanta System SpA, cleared under FDA 510(k) K160368 on 5 Apr 2016 and listed in FDA GUDID since 14 Dec 2018 (UDI-DI 08059173390137), 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	Number08059173390137 UDI-DI	Date14 Dec 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK160368	Date5 Apr 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08059173390137
FDA 510(k) database 510(k) number K160368

Across registries

2 registries list this device

FDA 510(k) K160368 decided 5 Apr 2016 Active
FDA GUDID UDI-DI 08059173390137 listed 14 Dec 2018 Listed

Timeline

2 dated events

5 Apr 2016 Cleared FDA 510(k) K160368
14 Dec 2018 Listed FDA GUDID 08059173390137

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Twain Evo
Generic name: Light-energy skin surface treatment system applicator
Model / reference: OAM002017

Primary DI / UDI-DI: 08059173390137
510(k) Number: K160368
FDA product code: GEX
GMDN term: Light-energy skin surface treatment system applicator

Device class: Class II
Regulation number: 878.4810
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)