The following data is part of a premarket notification filed by Dermascalp Llc with the FDA for Dermascalp Laser Cap.
| Device ID | K173846 |
| 510k Number | K173846 |
| Device Name: | DermaScalp Laser Cap |
| Classification | Laser, Comb, Hair |
| Applicant | DermaScalp LLC 190 E. Stacy Rd Suite 306-291 Allen, TX 75002 |
| Contact | John Carullo |
| Correspondent | John Carullo DermaScalp LLC 190 E. Stacy Rd Suite 306-291 Allen, TX 75002 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-19 |
| Decision Date | 2018-03-21 |
| Summary: | summary |