The following data is part of a premarket notification filed by Capillus with the FDA for Capillus 112, Capillus 244.
| Device ID | K192012 |
| 510k Number | K192012 |
| Device Name: | Capillus 112, Capillus 244 |
| Classification | Laser, Comb, Hair |
| Applicant | Capillus 1715 NW 82nd Ave. Doral, FL 33126 |
| Contact | Patricia Schnoor |
| Correspondent | Patricia Schnoor Capillus 1715 NW 82nd Ave. Doral, FL 33126 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2019-09-12 |
| Summary: | summary |