Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NUNA LUX (NUNL528)

K-Number: K233862 · 2024-03-01

ApplicantPremier North America, Inc.
Decision Date2024-03-01
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NUNA LUX (NUNL528) is a medical device manufactured by Premier North America, Inc.. It received FDA 510(k) clearance on 2024-03-01 under approval number K233862. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUNA LUX (NUNL528)?

NUNA LUX (NUNL528) is a medical device that received FDA 510(k) clearance on 2024-03-01. It is manufactured by Premier North America, Inc.. The 510(k) number is K233862.

When was NUNA LUX (NUNL528) approved by the FDA?

NUNA LUX (NUNL528) received FDA 510(k) clearance on 2024-03-01, under approval number K233862.

What company makes NUNA LUX (NUNL528)?

NUNA LUX (NUNL528) is manufactured by Premier North America, Inc..

What is the FDA product code for NUNA LUX (NUNL528)?

The FDA product code for NUNA LUX (NUNL528) is OHS.

Other Devices by Premier North America, Inc.

K181659Avologi ENEO K214100Luminice K213841ENEO TOTALE (Model: ENEOT947) K232656BLU TOTALE (Model: ENEOB852) K220735Avologi Gel Primer (Model: Av25)

Related Devices (Code: OHS)

K161849BrightTanda Beauty Canada, Inc. K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity K151337StrialiteCentre Light Solutions, LLC K171323BIOPHOTAS CELLUMA3Biophotas, Inc. K170984LG BEAUTY LED MASKLg Electronics K171386dpl SpectraLiteLed Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑