The following data is part of a premarket notification filed by Nutra Luxe Md, Llc with the FDA for Pulsaderm Ace-all Blue.
| Device ID | K162371 |
| 510k Number | K162371 |
| Device Name: | Pulsaderm ACE-All Blue |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | Nutra Luxe MD, LLC 12801 Commonwealth Dr. Unit 5 Fort Meyers, FL 33913 |
| Contact | Gloria Avendano |
| Correspondent | Gloria Avendano Nutra Luxe MD, LLC 12801 Commonwealth Dr. Unit 5 Fort Meyers, FL 33913 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-24 |
| Decision Date | 2016-12-15 |