The following data is part of a premarket notification filed by Capillus, Llc with the FDA for Capillus82.
| Device ID | K151516 |
| 510k Number | K151516 |
| Device Name: | Capillus82 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-05 |
| Decision Date | 2015-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853327006206 | K151516 | 000 |