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510(k) K231409

Device
Erchonia FX-405
Applicant
Erchonia Corporation
510(k) number
K231409
Product code
NHN
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-11
Date received
2023-05-15
Regulation
890.5500
Classification name
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Medical specialty
Physical Medicine
Review panel
Physical Medicine
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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K180197Erchonia FX-635Erchonia Corporation2018-05-21
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