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Elec-LED

by Micro-Nx Co., Ltd.

510(k) K201191

Elec-LED is a Class I device made by Micro-Nx Co., Ltd., cleared under FDA 510(k) K201191 on 7 Feb 2022 and registered in EUDAMED, active as of 22 Oct 2026.

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201191↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK201191 Date7 Feb 2022ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201191 decided 7 Feb 2022 Active
  • EUDAMED Active

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
EBW
Device class
Class I
Regulation
21 CFR Part 872.4200
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K201191

4 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K201191
UDI-DISize and differences
ELEC-LED EL-B40I
MICRO-NX CO., LTD.
EL-B40I08800029600098 —On the market
ELEC-LED EL-B40L
MICRO-NX CO., LTD.
EL-B40L08800029600081 —On the market
ELEC-LED EL-B40M
MICRO-NX CO., LTD.
EL-B40M08800029600104 —On the market
ELEC-LED EL-B40S
MICRO-NX CO., LTD.
EL-B40S08800029600074 —On the market

Similar devices

Other devices filed under FDA product code EBW (Controller, Foot, Handpiece And Cord).

Other devices from Micro-Nx Co., Ltd.

See all devices from Micro-Nx Co., Ltd. →