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Erchonia CLX CFL

by Erchonia Corporation

Erchonia CLX CFL is a Class II device made by Erchonia Corporation, cleared under FDA 510(k) K252574 on 15 Dec 2025 and listed in FDA GUDID since 21 Jul 2026 (UDI-DI 00858985006391), 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) K252574

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 Number00858985006391 UDI-DI Date21 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK252574 Date15 Dec 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K252574 decided 15 Dec 2025 Active
  • FDA GUDID UDI-DI 00858985006391 listed 21 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K252574
  2. Listed FDA GUDID 00858985006391

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Erchonia CLX
Generic name
Low-intensity laser fat liquefaction system, hand-held
Model / Ref / Catalog
CFL
Primary DI / UDI-DI
00858985006391
510(k) Number
FDA product code
OLI
GMDN term
Low-intensity laser fat liquefaction system, hand-held
Device class
Class II
Regulation number
878.5400
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code OLI (Fat Reducing Low Level Laser).

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See all devices from Erchonia Corporation →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)