The following data is part of a premarket notification filed by Nutra Luxe Md Llc with the FDA for Nutrastim Hair Laser Helmet.
| Device ID | K160728 |
| 510k Number | K160728 |
| Device Name: | NutraStim Hair Laser Helmet |
| Classification | Laser, Comb, Hair |
| Applicant | NUTRA LUXE MD LLC 12801 COMMONWEALTH DR. UNIT 2-6 Fort Myers, FL 33976 |
| Contact | Gloria Avendano |
| Correspondent | Gloria Avendano NUTRA LUXE MD LLC 12801 COMMONWEALTH DR. UNIT 2-6 Fort Myers, FL 33976 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-16 |
| Decision Date | 2016-09-16 |
| Summary: | summary |