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510(k) Data Aggregation
K Number
K233550Device Name
MOSAIC 3D (Surgical Laser)
Manufacturer
Lutronic Aesthetic
Date Cleared
2024-01-02
(60 days)
Product Code
ONG, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Lutronic Aesthetic
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MOSAIC 3D Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for fractional skin resurfacing procedures.
Device Description
The MOSAIC 3D Laser System is a non-ablative fractional Er:Glass (Erbium Glass) laser with a wavelength of 1550 nm. It uses Er:Glass to emit a laser beam that is then emitted onto the treatment area via the handpiece connected to the optical fiber of the main body of the system. It is comprised of a main body, a handpiece connected to an optical fiber, a tip, a footswitch, and goggles for laser protection. The laser beam is emitted onto the area to be treated through the tips (roller tip, sapphire tip, comb tip, pill tip) connected to the handpiece.
When the beam contacts tissue the laser beam emits many separate microbeams and creates a microscopic treatment zone (MTZ). Thermal coagulation is then induced in the dermis using the principle of fractional photo thermolysis, sparing the normal skin tissue surrounding the MTZ area. When the laser beam is emitted onto skin tissue, the energy of the beam is absorbed by specific tissues or chromophores such as water and is then converted into thermal energy, causing thermal damage to produce a therapeutic effect.
The MOSAIC 3D Laser System is controlled via a LCD touchscreen guided user interface in the front of the device, which is used to easily configure optimal treatment parameters and check parameters set in the device in the current system mode.
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