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Plexr Plus H

by Gmv SRL

Plexr Plus H is a thermo-mechanical skin surface treatment system (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Gmv SRL, cleared under FDA 510(k) K210693 on 22 Mar 2022 and listed in FDA GUDID since 10 Jan 2024 (UDI-DI 08057506440108), 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) K210693

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 Number08057506440108 UDI-DI Date10 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210693 Date22 Mar 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210693 decided 22 Mar 2022 Active
  • FDA GUDID UDI-DI 08057506440108 listed 10 Jan 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210693
  2. Listed FDA GUDID 08057506440108

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Plexr Plus
Generic name
Thermo-mechanical skin surface treatment system
Model / reference
PLEXR PLUS H
Primary DI / UDI-DI
08057506440108
510(k) Number
FDA product code
GEI
GMDN term
Thermo-mechanical skin surface treatment system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Thermo-mechanical skin surface treatment system

Cleared under the same submission (K210693)

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Other devices from Gmv SRL

  • Plexr Plus L

    Class II

  • Plexr Plus M

    Class II

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)