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Leaf life LM-LNIRA

by Shenzhen Leaflife Technology Co., Ltd.

Ref LM-LNIRAModel LM-L808A

Leaf life LM-LNIRA is a dermatological diode laser system (EU MDR Class IIb; FDA Class II; FDA product code OHT, Light Based Over-The-Counter Hair Removal) made by Shenzhen Leaflife Technology Co., Ltd., registered in EUDAMED on 26 Aug 2026 (Basic UDI-DI 697422365LM-L/HRL3), cleared under FDA 510(k) K220103 on 12 Apr 2022 and listed in FDA GUDID since 5 Nov 2022 (UDI-DI 06974223650004), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 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) K220103

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697422365LM-L/HRL3 Basic UDI-DI 06974223650004UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06974223650004 UDI-DI Date5 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK220103 Date12 Apr 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 697422365LM-L/HRL3 registered 26 Aug 2026 Active
  • FDA 510(k) K220103 decided 12 Apr 2022 Active
  • FDA GUDID UDI-DI 06974223650004 listed 5 Nov 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K220103
  2. Listed FDA GUDID 06974223650004
  3. Registered EUDAMED 697422365LM-L/HRL3

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Leaf life
Generic name
Dermatological diode laser system
Device name
Laser Therapy Device
Model / reference
LM-LNIRA, LM-L808A
Primary DI / UDI-DI
06974223650004
Basic UDI-DI
697422365LM-L/HRL3
510(k) Number
FDA product code
OHT
EMDN code
Z120615 Therapeutic lasers
GMDN term
Dermatological diode laser system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4810
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dermatological diode laser system

Cleared under the same submission (K220103)

Similar devices in this category

Other devices filed under THERAPEUTIC LASERS.

Other devices from Shenzhen Leaflife Technology Co., Ltd.

See all devices from Shenzhen Leaflife Technology Co., Ltd. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)