Erchonia Medical, Inc.: FDA clearances and approvals
Erchonia Medical, Inc. has 10 FDA 510(k) clearances (first 2004, latest 2016), plus 1 De Novo decision, across 5 product codes in 2 review panels. Median 510(k) review time: 156 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 108 |
| 2013 | 3 | 44 |
| 2014 | 1 | 207 |
| 2015 | 0 | — |
| 2016 | 1 | 214 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | 5 | 5 |
| OLI | Fat Reducing Low Level Laser | 3 | 2 |
| EGJ | Device, Iontophoresis, Other Uses | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 1 | 1 |
Review panels
Most recent Erchonia Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153164 | LunulaLaser | PDZ | 2016-06-03 | 214 |
| K132940 | ERCHONIA ALLAY | NHN | 2014-04-14 | 207 |
| K130996 | ERCHONIA EMERGE | NHN | 2013-09-16 | 159 |
| K130922 | ERCHONIA VERJU LASER SYSTEM WITH MASSAGER | OLI | 2013-05-17 | 44 |
| K130741 | ERCHONIA PL5000 | NHN | 2013-04-23 | 35 |
| K120257 | MLS, ZERONA-AD | OLI | 2012-05-14 | 108 |
| K072206 | ERCHONIA EML LASER | NHN | 2008-04-24 | 260 |
| K062792 | ERCHONIA IOTO_240 | EGJ | 2007-03-01 | 164 |
| K050672 | ERCHONIA EVRL LASER | GEX | 2005-05-02 | 48 |
| K041139 | ERCHONIA EML LASER | NHN | 2004-09-30 | 153 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN090008 | De Novo | Fat Reducing Low Level Laser | 2010-08-24 |
Recalls
openFDA lists no recalls under a recalling firm named Erchonia Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Erchonia Medical, Inc. have?
Erchonia Medical, Inc. has 10 FDA 510(k) clearances (first 2004, latest 2016), plus 1 De Novo decision, across 5 product codes in 2 review panels.
How long does FDA take to clear Erchonia Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Erchonia Medical, Inc.'s cleared 510(k)s is 156 days.
What devices does Erchonia Medical, Inc. make?
Its most frequent FDA product codes are 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).
Has Erchonia Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Erchonia Medical, Inc. Related entities may recall under other names.
Next steps
- See all 10 Erchonia Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NHN, Erchonia Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.