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FDA 510(k)

MOSAIC 3D (Surgical Laser)

K-Number: K233550 · 2024-01-02

ApplicantLutronic Aesthetic
Decision Date2024-01-02
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MOSAIC 3D (Surgical Laser) is a medical device manufactured by Lutronic Aesthetic. It received FDA 510(k) clearance on 2024-01-02 under approval number K233550. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOSAIC 3D (Surgical Laser)?

MOSAIC 3D (Surgical Laser) is a medical device that received FDA 510(k) clearance on 2024-01-02. It is manufactured by Lutronic Aesthetic. The 510(k) number is K233550.

When was MOSAIC 3D (Surgical Laser) approved by the FDA?

MOSAIC 3D (Surgical Laser) received FDA 510(k) clearance on 2024-01-02, under approval number K233550.

What company makes MOSAIC 3D (Surgical Laser)?

MOSAIC 3D (Surgical Laser) is manufactured by Lutronic Aesthetic.

What is the FDA product code for MOSAIC 3D (Surgical Laser)?

The FDA product code for MOSAIC 3D (Surgical Laser) is ONG.

Related Clinical Trials

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Related Devices (Code: ONG)

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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.

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