MOSAIC 3D (Surgical Laser)— 510(k) K233550

Substantially Equivalent

Lutronic Aesthetic

FDA 510(k) clearance K233550 for MOSAIC 3D (Surgical Laser), Substantially Equivalent on 2024-01-02. Applicant: Lutronic Aesthetic. Device class: 2.

Clearance details

Applicant: Lutronic Aesthetic
Product code: Code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2023-11-03
Decision date: 2024-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, US

Download summary PDF View on FDA.gov ↗

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