510(k) K180197 ยท NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Erchonia FX-635
| Applicant | Erchonia Corporation, Melbourne FL, US |
| Decision | Substantially Equivalent, May 21, 2018 |
| Received | Jan 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180197
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.