The following data is part of a premarket notification filed by Advihair S.r.l. with the FDA for Tricoglam Home Use.
| Device ID | K193008 |
| 510k Number | K193008 |
| Device Name: | Tricoglam Home Use |
| Classification | Laser, Comb, Hair |
| Applicant | Advihair S.R.L. Via Benini 11 Zola Predosa, IT 40069 |
| Contact | Angleo D’andrea |
| Correspondent | Angleo D’andrea Advihair S.R.L. Via Benini 11 Zola Predosa, IT 40069 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-28 |
| Decision Date | 2020-12-03 |