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

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 the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Aesthetic. It received FDA 510(k) clearance on 2024-01-02 under 510(k) 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. The listed applicant is Lutronic Aesthetic. The 510(k) number is K233550.

When did MOSAIC 3D (Surgical Laser) receive FDA 510(k) clearance?

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

Who is the listed applicant for MOSAIC 3D (Surgical Laser)?

The FDA 510(k) record lists Lutronic Aesthetic as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: ONG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.K244060eCO2 3DLutronic CorporationK251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.K223871Miria Skin Treatment SystemAVAVA, Inc.K221268SR-1 Skin Treatment SystemAVAVA, 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.

↑