The following data is part of a premarket notification filed by Nutra Luxe Md, Llc with the FDA for Nutra Stim Hair Laser Comb.
Device ID | K141596 |
510k Number | K141596 |
Device Name: | NUTRA STIM HAIR LASER COMB |
Classification | Laser, Comb, Hair |
Applicant | NUTRA LUXE MD, LLC 5575 SANTA ROSA CT. Sparks, NV 89436 |
Contact | Jill Creasy |
Correspondent | Jill Creasy NUTRA LUXE MD, LLC 5575 SANTA ROSA CT. Sparks, NV 89436 |
Product Code | OAP |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-13 |
Decision Date | 2015-01-08 |
Summary: | summary |