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Deka Sculpt M116H1

by El.en. SpA

Deka Sculpt M116H1 is a microwave hyperthermia system applicator (FDA Class II; FDA product code PBX, Massager, Vacuum, Radio Frequency Induced Heat) made by El.en. SpA, cleared under FDA 510(k) K211091 on 15 Oct 2021 and listed in FDA GUDID since 27 Apr 2023 (UDI-DI 08057017760719), 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) K211091

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 Number08057017760719 UDI-DI Date27 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211091 Date15 Oct 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211091 decided 15 Oct 2021 Active
  • FDA GUDID UDI-DI 08057017760719 listed 27 Apr 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211091
  2. Listed FDA GUDID 08057017760719

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Deka Sculpt
Generic name
Microwave hyperthermia system applicator, extracorporeal
Model / Ref / Catalog
M116H1
Primary DI / UDI-DI
08057017760719
510(k) Number
FDA product code
PBX
GMDN term
Microwave hyperthermia system applicator, extracorporeal
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Microwave hyperthermia system applicator, extracorporeal

Cleared under the same submission (K211091)

Similar devices

Other devices filed under FDA product code PBX (Massager, Vacuum, Radio Frequency Induced Heat).

Other devices from El.en. SpA

See all devices from El.en. SpA →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)