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Potenza

by Jeisys Medical Inc.

Ref 16Model POTENZA

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231216↗

+2 more

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK231216 Date10 Dec 2024IssuedStatusActive
European UnionCE/MDD EUDAMED NumberB-08800020101785 Basic UDI-DI 08800020101785UDI-DIDate22 Nov 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231216 decided 10 Dec 2024 Active· +2 more in the status table
  • EUDAMED Basic UDI-DI B-08800020101785 registered 22 Nov 2024 Active

Timeline

4 dated events

  1. Cleared FDA 510(k) K201685
  2. Cleared FDA 510(k) K231287
  3. Registered EUDAMED B-08800020101785
  4. Cleared FDA 510(k) K231216

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k)

Model / reference
POTENZA, 16
Primary DI / UDI-DI
08800020101785
Basic UDI-DI
B-08800020101785
EMDN code
Z12010902 Electrosurgical units (esu) for general use
Device class
Class IIb
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
KR-MF-000008513
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Potenza is a radiofrequency (RF) microneedling device classified under nomenclature code Z12010902, designed for non-invasive skin rejuvenation. It delivers controlled RF energy through microneedles to stimulate collagen production, improve skin texture, and address mild to moderate skin laxity or scarring. The device operates without implantable components, medicinal administration, or animal-derived materials, adhering to Class IIb regulatory standards.

This single-use device is non-sterile and intended for professional use in clinical or aesthetic settings. It is not reusable or reprocessed and requires no special MRI safety considerations. Supplied as a standalone unit with a reference code of 16, it is authorized under FDA 510K and MDD directives. Storage and handling follow standard medical device protocols, with compliance ensured through a Basic UDI (B-08800020101785) and regulatory oversight by Emergo Europe B.V.

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Properties

Other properties (12, all answered No)