The following data is part of a premarket notification filed by Daavlin Distributing Co. with the FDA for 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4.
| Device ID | K100378 |
| 510k Number | K100378 |
| Device Name: | 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. Bryan, OH 43506 |
| Contact | Michele Thiel |
| Correspondent | Michele Thiel DAAVLIN DISTRIBUTING CO. 205 WEST BEMENT ST. 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 | 2010-02-16 |
| Decision Date | 2010-04-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B280807OS0400X6A10 | K100378 | 000 |
| B280806OS0004CX50 | K100378 | 000 |
| B280807OS0004CX5BL0 | K100378 | 000 |
| B280806OS0004CX60 | K100378 | 000 |
| B280807OS0004CX50 | K100378 | 000 |
| B280807OS0004CX60 | K100378 | 000 |
| B280807OS0004CX6BL04 | K100378 | 000 |
| B280806OS0004T60 | K100378 | 000 |
| B280806OS0004X60 | K100378 | 000 |
| B280807OS0004T60 | K100378 | 000 |
| B280807OS0004T6BL0 | K100378 | 000 |
| B280807OS0004X60 | K100378 | 000 |
| B280807OS0004X6BL0 | K100378 | 000 |
| B280807OS0400T60 | K100378 | 000 |
| B280807OS0400T6A10 | K100378 | 000 |
| B280807OS0400T6SD0 | K100378 | 000 |
| B280807OS0400X60 | K100378 | 000 |
| B280807OS0400CX50 | K100378 | 000 |