Nutra Luxe MD, LLC: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Nutra Luxe MD, LLC” (first 2014, latest 2016), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 184 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 2 | 174 |
| 2015 | 3 | 209 |
| 2016 | 4 | 148 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 4 | 4 |
| OAP | Laser, Comb, Hair | 3 | 3 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 1 | 1 |
| OHS | Light Based Over The Counter Wrinkle Reduction | 1 | 1 |
Review panels
Most recent Nutra Luxe MD, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162371 | Pulsaderm ACE-All Blue | OLP | 2016-12-15 | 113 |
| K161941 | Pulsaderm Acne Device | OLP | 2016-10-19 | 96 |
| K160728 | NutraStim Hair Laser Helmet | OAP | 2016-09-16 | 184 |
| K150826 | Nutra Face Lift Model PE8050 | NFO | 2016-02-10 | 317 |
| K150370 | Nutra Light Advanced | OLP | 2015-07-22 | 159 |
| K141596 | NUTRA STIM HAIR LASER COMB | OAP | 2015-01-08 | 209 |
| K141588 | NUTRA STIM HAIR LASER COMB | OAP | 2015-01-08 | 209 |
| K141308 | NUTRA LIGHT RED | OHS | 2014-08-20 | 93 |
| K132838 | NUTRA LIGHT BLUE | OLP | 2014-05-23 | 255 |
Recalls
openFDA lists no recalls under a recalling firm named Nutra Luxe MD, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nutra Luxe MD, LLC?
FDA lists 9 510(k) clearances under the applicant name “Nutra Luxe MD, LLC” (first 2014, latest 2016), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nutra Luxe MD, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nutra Luxe MD, LLC is 184 days.
Which FDA product codes appear under Nutra Luxe MD, LLC?
The most frequent FDA product codes under this applicant name are OLP (Over-The-Counter Powered Light Based Laser For Acne, 4); OAP (Laser, Comb, Hair, 3); NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes, 1).
Next steps
- See all 9 Nutra Luxe MD, LLC clearances with predicates and recalls
- Run predicate analysis for product code OLP, Nutra Luxe MD, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.