The following data is part of a premarket notification filed by Erchonia Corporation with the FDA for Erchonia Fx-635.
| Device ID | K180197 |
| 510k Number | K180197 |
| Device Name: | Erchonia FX-635 |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | Erchonia Corporation 650 Atlantis Rd. Melbourne, FL 32904 |
| Contact | Steven Shanks |
| Correspondent | Kevin Walls Regulatory Insight, 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 | 2018-01-24 |
| Decision Date | 2018-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858985006049 | K180197 | 000 |