The following data is part of a premarket notification filed by Erchonia Corporation with the FDA for Erchonia Xlr8.
| Device ID | K211186 |
| 510k Number | K211186 |
| Device Name: | Erchonia XLR8 |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | Erchonia Corporation 650 Atlantis Road Melbourne, FL 32904 |
| Contact | Steven Shanks |
| Correspondent | Travis Sammons Erchonia Corporation 650 Atlantis Road Melbourne, FL 32904 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-20 |
| Decision Date | 2021-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858985006094 | K211186 | 000 |