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LeafPure-Echo LM-LPNdA

by Shenzhen Leaflife Technology Co., Ltd.

LeafPure-Echo LM-LPNdA is a dermatological solid-state laser system (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Shenzhen Leaflife Technology Co., Ltd., cleared under FDA 510(k) K253219 on 25 Nov 2025 and listed in FDA GUDID since 22 Apr 2026 (UDI-DI 06974223650110), active as of 22 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 22 Oct 2026

Documents

510(k) K253219

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06974223650110 UDI-DI Date22 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK253219 Date25 Nov 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K253219 decided 25 Nov 2025 Active
  • FDA GUDID UDI-DI 06974223650110 listed 22 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K253219
  2. Listed FDA GUDID 06974223650110

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
LeafPure-Echo
Generic name
Dermatological solid-state laser system
Model / reference
LM-LPNdA
Primary DI / UDI-DI
06974223650110
510(k) Number
FDA product code
GEX
GMDN term
Dermatological solid-state laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Shenzhen Leaflife Technology Co., Ltd.

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

Properties

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