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Premier North America, Inc.

5 FDA records filed under this company name, from 2018 to 2024, in light for wrinkles (OHS, 3), light for acne (OLP, 1), microcurrent and ems (NFO, 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 wrinkles (OHS, 3)

510(k) clearedMar 1, 2024

NUNA LUX (NUNL528)

510(k) number: K233862
Applicant: Premier North America, Inc.
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Dec 6, 2023

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 6, 2022

ENEO TOTALE (Model: ENEOT947)

510(k) number: K213841
Applicant: Premier North America, Inc.
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Dec 9, 2021

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 3.

FDA database record FDA document (PDF)

510(k) clearedJul 26, 2018

Avologi ENEO

510(k) number: K181659
Applicant: Premier North America, Inc.
Product code: OHS: Light Based Over The Counter Wrinkle Reduction
Regulation: 21 CFR 878.4810, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Jun 25, 2018

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)

LED and light devices for acne (OLP, 1)

510(k) clearedNov 14, 2023

BLU TOTALE (Model: ENEOB852)

510(k) number: K232656
Applicant: Premier North America, Inc.
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 31, 2023

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 24, 2022

Luminice

510(k) number: K214100
Applicant: Premier North America, Inc.
Product code: NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation: 21 CFR 882.5890, Class II
FDA decision: Substantially Equivalent (SESE)
Received: Dec 29, 2021

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)