The following data is part of a premarket notification filed by Erchonia Medical Inc with the FDA for Erchonia Pl5000.
| Device ID | K130741 |
| 510k Number | K130741 |
| Device Name: | ERCHONIA PL5000 |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | ERCHONIA MEDICAL INC 33 Golden Eagle Lane Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls ERCHONIA MEDICAL INC 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-19 |
| Decision Date | 2013-04-23 |