ClearanceBrief
Company ยท US

Premier North America, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2024. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
OHSLight Based Over The Counter Wrinkle Reduction3
GYBMedia, Electroconductive1
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes1
OLPOver-The-Counter Powered Light Based Laser For Acne1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Mar 1, 2024K233862NUNA LUX (NUNL528)
Premier North America, Inc.
OHS
Nov 14, 2023K232656BLU TOTALE (Model: ENEOB852)
Premier North America, Inc.
OLP
Sep 15, 2023K220735Avologi Gel Primer (Model: Av25)
Premier North America, Inc.
GYB
Feb 24, 2022K214100Luminice
Premier North America, Inc.
NFO
Jan 6, 2022K213841ENEO TOTALE (Model: ENEOT947)
Premier North America, Inc.
OHS
Jul 26, 2018K181659Avologi ENEO
Premier North America, Inc.
OHS

Latest recalls

DateFirm and productCodeLinked 510(k)
No recalls in this window.
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