The following data is part of a premarket notification filed by Erchonia Corporation with the FDA for Erchonia Zerona Z-bed.
| Device ID | K220519 |
| 510k Number | K220519 |
| Device Name: | Erchonia Zerona Z-Bed |
| Classification | Fat Reducing Low Level Laser |
| Applicant | Erchonia Corporation 650 Atlantis Road Melbourne, FL 32904 |
| Contact | Travis Sammons |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | OLI |
| CFR Regulation Number | 878.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-02-23 |
| Decision Date | 2022-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858985006261 | K220519 | 000 |