The following data is part of a premarket notification filed by Nutra Luxe Md, Llc with the FDA for Nutra Light Blue.
| Device ID | K132838 |
| 510k Number | K132838 |
| Device Name: | NUTRA LIGHT BLUE |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| 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 | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-10 |
| Decision Date | 2014-05-23 |
| Summary: | summary |