FDA.reportPublic FDA data

510(k) K231474

Device
Erchonia Violet ZERONA® Z6 OTC
Applicant
Erchonia Corporation
510(k) number
K231474
Product code
OLI
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-21
Date received
2023-05-22
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
No

Applicant Contact#

Contact
Travis Sammons
Address
650 Atlantis Rd. Melbourne FL US 32904 32904

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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