Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine— 510(k) K210545

Name: FDA 510(k) clearance K210545
Creator: U.S. Food and Drug Administration
Published: 2022-05-20

Substantially Equivalent

Marci Beauty, Inc.

FDA 510(k) clearance K210545 for Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Substantially Equivalent on 2022-05-20. Applicant: Marci Beauty, Inc.. Device class: 2.

Clearance details

Applicant: Marci Beauty, Inc.
Product code: Code OLP
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2021-02-25
Decision date: 2022-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OLP

product code OLP

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.