VIVEVE Footswitch VIVFS01

by Viveve, Inc.

VIVEVE Footswitch VIVFS01 is a Class II device made by Viveve, Inc., cleared under FDA 510(k) K082962 on 4 Dec 2008 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00850794007170), active as of 22 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850794007170 UDI-DI	Date23 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK082962	Date4 Dec 2008Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00850794007170
FDA 510(k) database 510(k) number K082962

Across registries

2 registries list this device

FDA 510(k) K082962 decided 4 Dec 2008 Active
FDA GUDID UDI-DI 00850794007170 listed 23 Sep 2016 Listed

Timeline

2 dated events

4 Dec 2008 Cleared FDA 510(k) K082962
23 Sep 2016 Listed FDA GUDID 00850794007170

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: VIVEVE Footswitch
Generic name: Radio-frequency skin/body contouring system
Model / Ref / Catalog: VIVFS01

Primary DI / UDI-DI: 00850794007170
510(k) Number: K082962
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 Viveve, Inc.

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Properties

Prescription use

Other properties (14, all answered No)