Home / Companies / Nutra Luxe MD, LLC

Nutra Luxe MD, LLC

9 FDA records filed under this company name, from 2014 to 2016, in light for acne (OLP, 4), hair growth (OAP, 3), microcurrent and ems (NFO, 1), light for wrinkles (OHS, 1).

The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.

LED and light devices for acne (OLP, 4)

510(k) clearedDec 15, 2016

Pulsaderm ACE-All Blue

510(k) number: K162371
Applicant: Nutra Luxe MD, LLC
Product code: OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Aug 24, 2016

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database record FDA document (PDF)

510(k) clearedOct 19, 2016

Pulsaderm Acne Device

510(k) number: K161941
Applicant: Nutra Luxe MD, LLC
Product code: OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Jul 15, 2016

Indications for use, as filed

“Pulsaderm Acne Device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database record FDA document (PDF)

510(k) clearedJul 22, 2015

Nutra Light Advanced

510(k) number: K150370
Applicant: Nutra Luxe MD, LLC
Product code: OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Feb 13, 2015

Indications for use

Not quoted here. The statement contains words we couldn't confirm (a typo, run-together words or a reading error), and we don't correct FDA's text. Read FDA's PDF, page 3.

FDA database record FDA document (PDF)

510(k) clearedMay 23, 2014

NUTRA LIGHT BLUE

510(k) number: K132838
Applicant: Nutra Luxe MD, LLC
Product code: OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Sep 10, 2013

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 6.

FDA database record FDA document (PDF)

Laser and LED hair-growth caps, helmets and combs (1 record says prescription use) (OAP, 3)

510(k) clearedSep 16, 2016

NutraStim Hair Laser Helmet

510(k) number: K160728
Applicant: Nutra Luxe MD, LLC
Product code: OAP: Laser, Comb, Hair
Regulation: 21 CFR 890.5500, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Mar 16, 2016

Indications for use

Not quoted here. The statement's clinical classification text (such as Norwood-Hamilton or Ludwig-Savin ranges) doesn't read cleanly, so we don't quote it rather than guess at a correction. Read FDA's PDF, page 3.

FDA database record FDA document (PDF)

510(k) clearedJan 8, 2015

NUTRA STIM HAIR LASER COMB

510(k) number: K141588
Applicant: Nutra Luxe MD, LLC
Product code: OAP: Laser, Comb, Hair
Regulation: 21 CFR 890.5500, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Jun 13, 2014

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database record FDA document (PDF)

510(k) clearedJan 8, 2015

NUTRA STIM HAIR LASER COMB

510(k) number: K141596
Applicant: Nutra Luxe MD, LLC
Product code: OAP: Laser, Comb, Hair
Regulation: 21 CFR 890.5500, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Jun 13, 2014

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database record FDA document (PDF)

Electrical stimulation for aesthetic use (microcurrent and EMS) (NFO, 1)

510(k) clearedFeb 10, 2016

Nutra Face Lift Model PE8050

510(k) number: K150826
Applicant: Nutra Luxe MD, LLC
Product code: NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation: 21 CFR 882.5890, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Mar 30, 2015

Indications for use, as filed

“The Nutra Face LIFT Model PE8050 device is intended for facial stimulation and indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database record FDA document (PDF)

LED and light devices for wrinkles (OHS, 1)

510(k) clearedAug 20, 2014

NUTRA LIGHT RED

510(k) number: K141308
Applicant: Nutra Luxe MD, LLC
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: May 19, 2014

Indications for use

Not quoted here. We couldn't find a clean, complete statement in FDA's PDF, so we don't quote one. Read FDA's PDF.

FDA database record FDA document (PDF)