The following data is part of a premarket notification filed by Nutra Luxe Md, Llc with the FDA for Nutra Light Advanced.
| Device ID | K150370 |
| 510k Number | K150370 |
| Device Name: | Nutra Light Advanced |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | NUTRA LUXE MD, LLC 6835 INTERNATIONAL CENTER BLVD UNIT 4-5 Fort Myers, FL 33912 |
| Contact | Gloria Avendano |
| Correspondent | Gloria Avendano NUTRA LUXE MD, LLC 6835 INTERNATIONAL CENTER BLVD UNIT 4-5 Fort Myers, FL 33912 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-13 |
| Decision Date | 2015-07-22 |