The following data is part of a premarket notification filed by Erchonia Corporation with the FDA for Erchonia Gvl.
| Device ID | K221987 |
| 510k Number | K221987 |
| Device Name: | Erchonia GVL |
| 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 | Travis Sammons |
| 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 | 2022-07-06 |
| Decision Date | 2022-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858985006278 | K221987 | 000 |