The following data is part of a premarket notification filed by Capillus, Llc with the FDA for Capillus202.
| Device ID | K153618 |
| 510k Number | K153618 |
| Device Name: | Capillus202 |
| Classification | Laser, Comb, Hair |
| Applicant | CAPILLUS, LLC 1715 NW 82nd AVE Miami, FL 33126 |
| Contact | Patricia Schnoor |
| Correspondent | Patricia Schnoor CAPILLUS, LLC 1715 NW 82nd AVE 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 | 2015-12-18 |
| Decision Date | 2016-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853327006299 | K153618 | 000 |
| 00853327006213 | K153618 | 000 |