FAQ 102 Topaz

FAQ 102 Topaz is a Class II device made by Foreo Inc, cleared under FDA 510(k) K240616 on 15 Jul 2024 and listed in FDA GUDID since 18 Jul 2024 (UDI-DI 07640260120112), 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	Number07640260120112 UDI-DI	Date18 Jul 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK240616	Date15 Jul 2024Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07640260120112
FDA 510(k) database 510(k) number K240616

Across registries

2 registries list this device

FDA 510(k) K240616 decided 15 Jul 2024 Active
FDA GUDID UDI-DI 07640260120112 listed 18 Jul 2024 Listed

Timeline

2 dated events

15 Jul 2024 Cleared FDA 510(k) K240616
18 Jul 2024 Listed FDA GUDID 07640260120112

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Faq 102
Generic name: Radio-frequency skin/body contouring system
Model / reference: Topaz

Primary DI / UDI-DI: 07640260120112
510(k) Number: K240616
FDA product code: NFO, PAY, OHS
GMDN term: Radio-frequency skin/body contouring system

Device class: Class II
Regulation number: 882.5890, 878.4420, 878.4810
GUDID distribution status: In Commercial Distribution

Similar devices in this category

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

Other devices from Foreo Inc

See all devices from Foreo Inc →

Properties

Over-the-counter
Serial number
Manufacturing date

Other properties (12, all answered No)