The following data is part of a premarket notification filed by Auxo Hair, Llc with the FDA for Auxo A300, A150 And Apod.
| Device ID | K220543 |
| 510k Number | K220543 |
| Device Name: | Auxo A300, A150 And APod |
| Classification | Laser, Comb, Hair |
| Applicant | Auxo Hair, LLC 16300 SW 101 Ave Miami, FL 33157 |
| Contact | Patricia Schnoor |
| Correspondent | Patricia Schnoor Auxo Hair, LLC 16300 SW 101 Ave Miami, FL 33157 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-25 |
| Decision Date | 2022-04-20 |