Erchonia Medical, Inc.
Greenwood Village, CO, US
Erchonia Medical, Inc. appears in FDA device records in Greenwood Village, CO. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Erchonia Medical, Inc. between 2004 and 2016. The busiest year on record is 2013, with 3. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 3 |
| 2014 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K153164 | LunulaLaser | PDZ | Substantially Equivalent | |
| K132940 | ERCHONIA ALLAY | NHN | Substantially Equivalent | |
| K130996 | ERCHONIA EMERGE | NHN | Substantially Equivalent | |
| K130922 | ERCHONIA VERJU LASER SYSTEM WITH MASSAGER | OLI | Substantially Equivalent | |
| K130741 | ERCHONIA PL5000 | NHN | Substantially Equivalent | |
| K120257 | MLS, ZERONA-AD | OLI | Substantially Equivalent | |
| DEN090008 | ERCHONIA ML SCANNER (MLS) | OLI | Unknown | |
| K072206 | ERCHONIA EML LASER | NHN | Substantially Equivalent | |
| K062792 | ERCHONIA IOTO_240 | EGJ | Substantially Equivalent | |
| K050672 | ERCHONIA EVRL LASER | GEX | Substantially Equivalent | |
| K041139 | ERCHONIA EML LASER | NHN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain