The following data is part of a premarket notification filed by Eglobal, Llc with the FDA for Illumiflow 148 Laser Cap.
Device ID | K173843 |
510k Number | K173843 |
Device Name: | Illumiflow 148 Laser Cap |
Classification | Laser, Comb, Hair |
Applicant | EGlobal, LLC 10115 E Bell Rd Suite 107 Scottsdale, AZ 85260 |
Contact | Wayne De Stefano |
Correspondent | Liza Burns Liza Burns And Associates 6469 G Kawaihau Road Kapaa, HI 96746 |
Product Code | OAP |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-18 |
Decision Date | 2018-01-26 |
Summary: | summary |