Medical Device Manufacturer · US , Fountain Inn , SC

Erchonia Corporation

26 submissions · 26 cleared · Since 2010
26
Total
26
Cleared
0
Denied

Erchonia Corporation — FDA 510(k) Submissions

Erchonia Corporation has submitted 26 FDA 510(k) premarket notifications since 2010, of which 26 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Fat Reducing Low Level Laser, Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy, Over-the-counter Powered Light Based Laser For Acne . Use the specialty filter in the sidebar to narrow results.

26 devices
1–25 of 26
Erchonia DPN Laser (Model# EVRL)
K251903 · NHN Powered Light Based Laser... · Physical Medicine
Feb 2026 244d
Erchonia CLX (Model # CFL)
K252574 · OLI Fat Reducing Low Level Laser · General & Plastic Surgery
Dec 2025 123d
Erchonia EVRL
K251843 · OLP Over-the-counter Powered... · General & Plastic Surgery
Sep 2025 88d
Erchonia Zerona? VZ8
K243811 · OLI Fat Reducing Low Level Laser · General & Plastic Surgery
Jan 2025 30d
Erchonia FX-405
K231409 · NHN Powered Light Based Laser... · Physical Medicine
Aug 2023 88d
Erchonia Violet ZERONA? Z6 OTC
K231474 · OLI Fat Reducing Low Level Laser · General & Plastic Surgery
Jul 2023 60d
Erchonia GVL
K221987 · NHN Powered Light Based Laser... · General & Plastic Surgery
Sep 2022 57d
Erchonia Zerona Z-Bed
K220519 · OLI Fat Reducing Low Level Laser · General & Plastic Surgery
Mar 2022 29d
Erchonia FX-405
K212595 · NHN Powered Light Based Laser... · Physical Medicine
Nov 2021 88d
Erchonia XLR8
K211186 · NHN Powered Light Based Laser... · Physical Medicine
Oct 2021 185d
Erchonia Emerald
K192544 · OLI Fat Reducing Low Level Laser · General & Plastic Surgery
Jan 2020 119d
Erchonia EVRL
K191257 · NHN Powered Light Based Laser... · General & Plastic Surgery
Aug 2019 90d
Erchonia FX-635
K190572 · NHN Powered Light Based Laser... · Physical Medicine
Jun 2019 87d
Erchonia FX-635
K180197 · NHN Powered Light Based Laser... · Physical Medicine
May 2018 117d
Zerona Z6 OTC
K162578 · OLI Fat Reducing Low Level Laser · General & Plastic Surgery
Dec 2016 92d
Erchonia EVRL
K152196 · NHN Powered Light Based Laser... · Physical Medicine
Feb 2016 197d
Erchonia PL Touch
K153052 · NHN Powered Light Based Laser... · Physical Medicine
Jan 2016 76d
Erchonia Zerona 6 headed scanner EZ6
K150446 · OLI Fat Reducing Low Level Laser · General & Plastic Surgery
May 2015 90d
Erchonia Zerona Z6 OTC
K143007 · OLI Fat Reducing Low Level Laser · General & Plastic Surgery
Jan 2015 87d
ERCHONIA SHL
K142042 · OLI Fat Reducing Low Level Laser · General & Plastic Surgery
Oct 2014 85d
ZERONA
K133718 · OLI Fat Reducing Low Level Laser · General & Plastic Surgery
May 2014 159d
ZERONA 2.0 LASER
K123237 · OLI Fat Reducing Low Level Laser · General & Plastic Surgery
Jan 2013 101d
ETCHONIA ZERONA ARMS
K121690 · OLI Fat Reducing Low Level Laser · General & Plastic Surgery
Aug 2012 77d
ERCHONIA ZERONA
K121695 · OLI Fat Reducing Low Level Laser · General & Plastic Surgery
Aug 2012 77d
MLS-AC DERMA SCANNER
K101430 · NHN Powered Light Based Laser... · Physical Medicine
Jun 2010 32d
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