The following data is part of a premarket notification filed by Nutra Luxe Md, Llc with the FDA for Nutra Face Lift Model Pe8050.
Device ID | K150826 |
510k Number | K150826 |
Device Name: | Nutra Face Lift Model PE8050 |
Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
Applicant | NUTRA LUXE MD, LLC 6835 INTERNATIONAL CENTER BLVD UNIT 4-5 Fort Myers, FL 33912 |
Contact | Peter Von Berg |
Correspondent | Gloria Avendano NUTRA LUXE MD, LLC 12801 COMMONWEALTH DR. UNITS 2-6 Fort Myers, FL 33913 |
Product Code | NFO |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-30 |
Decision Date | 2016-02-10 |
Summary: | summary |