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Coupling Fluid VIVCF02

by Viveve, Inc.

Coupling Fluid VIVCF02 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 3 Oct 2016 (UDI-DI 00850794007071), 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

510(k) K082962

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850794007071 UDI-DI Date3 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082962 Date4 Dec 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082962 decided 4 Dec 2008 Active
  • FDA GUDID UDI-DI 00850794007071 listed 3 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082962
  2. Listed FDA GUDID 00850794007071

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Coupling Fluid
Generic name
Radio-frequency skin/body contouring system
Model / Ref / Catalog
VIVCF02
Primary DI / UDI-DI
00850794007071
510(k) Number
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

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

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)