The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for 7 Series Phototherapy Device.
| Device ID | K212510 |
| 510k Number | K212510 |
| Device Name: | 7 Series Phototherapy Device |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | Daavlin Distributing Co. 205 W. Bement Street Bryan, OH 43506 |
| Contact | Michele Thiel |
| Correspondent | Michele Thiel Daavlin Distributing Co. 205 W. Bement Street Bryan, OH 43506 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-10 |
| Decision Date | 2021-11-04 |