Company ยท US
Erchonia Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2016. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | 5 |
| OLI | Fat Reducing Low Level Laser | 3 |
| EGJ | Device, Iontophoresis, Other Uses | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 2016 | K153164 | LunulaLaser Erchonia Medical, Inc. | PDZ |
| Apr 14, 2014 | K132940 | ERCHONIA ALLAY Erchonia Medical, Inc. | NHN |
| Sep 16, 2013 | K130996 | ERCHONIA EMERGE Erchonia Medical, Inc. | NHN |
| May 17, 2013 | K130922 | ERCHONIA VERJU LASER SYSTEM WITH MASSAGER Erchonia Medical, Inc. | OLI |
| Apr 23, 2013 | K130741 | ERCHONIA PL5000 Erchonia Medical, Inc. | NHN |
| May 14, 2012 | K120257 | MLS, ZERONA-AD Erchonia Medical, Inc. | OLI |
| Aug 24, 2010 | DEN090008 | ERCHONIA ML SCANNER (MLS) Erchonia Medical | OLI |
| Apr 24, 2008 | K072206 | ERCHONIA EML LASER Erchonia Medical, Inc. | NHN |
| Mar 1, 2007 | K062792 | ERCHONIA IOTO_240 Erchonia Medical, Inc. | EGJ |
| May 2, 2005 | K050672 | ERCHONIA EVRL LASER Erchonia Medical, Inc. | GEX |
| Sep 30, 2004 | K041139 | ERCHONIA EML LASER Erchonia Medical, Inc. | NHN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||