The following data is part of a premarket notification filed by Erchonia Corporation with the FDA for Erchonia Pl Touch.
| Device ID | K153052 |
| 510k Number | K153052 |
| Device Name: | Erchonia PL Touch |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | ERCHONIA CORPORATION 2021 COMMERCE DR Mckinney, TX 75069 |
| Contact | Steven Shanks |
| Correspondent | Kevin Walls REGULATORY INSIGHT, INC. 33 Golden Eagle Lane Litteton, CO 80127 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-20 |
| Decision Date | 2016-01-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858985006063 | K153052 | 000 |