The following data is part of a premarket notification filed by Capillus, Llc with the FDA for Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, And Capillus 352.
| Device ID | K163170 |
| 510k Number | K163170 |
| Device Name: | Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, And Capillus 352 |
| Classification | Laser, Comb, Hair |
| Applicant | CAPILLUS, LLC 1715 NW 82nd Avenue Miami, FL 33126 |
| Contact | Patricia Schnoor |
| Correspondent | Patricia Schnoor CAPILLUS, LLC 1715 NW 82nd Avenue Miami, FL 33126 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2017-01-31 |
| Summary: | summary |