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LipoSurg Power Standard Set 3396

by Nouvag AG

LipoSurg Power Standard Set 3396 is a Class II device made by Nouvag AG, cleared under FDA 510(k) K254135 on 5 Sep 2026 and listed in FDA GUDID since 18 Sep 2026 (UDI-DI 07640306733436), 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

510(k) K254135

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07640306733436 UDI-DI Date18 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK254135 Date5 Sep 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K254135 decided 5 Sep 2026 Active
  • FDA GUDID UDI-DI 07640306733436 listed 18 Sep 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K254135
  2. Listed FDA GUDID 07640306733436

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
LipoSurg Power Standard Set
Generic name
Liposuction system
Model / reference
3396
Description
LipoSurg Power Liposuction System (including control unit, powered handpiece, foot switch)
Primary DI / UDI-DI
07640306733436
510(k) Number
FDA product code
QPB
GMDN term
Liposuction system
Device class
Class II
Regulation number
878.5040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Nouvag AG

See all devices from Nouvag AG →

Properties

  • Sterilise before use
  • Prescription use
  • Convenience kit
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)