The following data is part of a premarket notification filed by Eglobal, Llc with the FDA for Illumiflow Laser Cap.
| Device ID | K162071 |
| 510k Number | K162071 |
| Device Name: | IllumiFlow Laser Cap |
| Classification | Laser, Comb, Hair |
| Applicant | EGLOBAL, LLC 10115 E BELL RD STE 107 Scottsdale, AZ 85260 |
| Contact | Wayne Destefano |
| Correspondent | Liza Burns LIZA BURNS AND ASSOCIATES 6469G KAWAIHAU RD Kapaa, HI 96746 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-27 |
| Decision Date | 2017-02-24 |
| Summary: | summary |