FDA.reportPublic FDA data

510(k) K252574

Device
Erchonia CLX (Model # CFL)
Applicant
Erchonia Corporation
510(k) number
K252574
Product code
OLI
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-15
Date received
2025-08-14
Regulation
878.5400
Classification name
Fat Reducing Low Level Laser
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Travis Sammons
Address
112 Southchase Blvd. Fountain Inn SC US 29644 29644

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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