MOSAIC 3D Surgical Laser
510(k) K233550
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK233550 | Date2 Jan 2024 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- ONG
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Mosaic 3D Surgical Laser is a Powered Laser Surgical Instrument with Microbeam Fractional Output, designed for precise tissue ablation and resurfacing. It operates at 1550 nm, delivering controlled fractional energy to superficial and mid-dermal skin layers. This device is classified as a Class II medical device under FDA regulations (878.4810) and is intended for use in general and plastic surgery procedures.
The Mosaic 3D Surgical Laser is supplied as a reusable medical device and is not sterile at time of shipment. It is intended for use in clinical settings, including surgical and aesthetic procedures, and must be sterilized prior to use. The device features multiple fractional energy settings (as indicated by the listed FEI numbers) and is compatible with standard surgical environments. FDA clearance (K233550) confirms its substantial equivalence to predicate devices under the 510(k) pathway.
Questions
AI-generated answers, 1 Oct 2026
What is the Mosaic 3D Surgical Laser used for?
The Mosaic 3D Surgical Laser is designed for precise tissue ablation and resurfacing in general and plastic surgery procedures. It operates at 1550nm wavelength, delivering controlled fractional energy to superficial and mid-dermal skin layers. This allows clinicians to target specific tissue depths while minimizing damage to surrounding areas, making it ideal for procedures requiring refined skin remodeling or scar revision.
Is the Mosaic 3D Surgical Laser sterile when received?
No, the Mosaic 3D Surgical Laser is not sterile at the time of shipment. It is a reusable device intended for clinical use and must be sterilized prior to each procedure. Sterilization ensures patient safety and device efficacy, as it removes contaminants that could compromise surgical outcomes or introduce infection risk.
How many fractional energy settings does the Mosaic 3D Surgical Laser offer?
The Mosaic 3D Surgical Laser features multiple fractional energy settings, each identified by a unique FEI (Fractional Energy Index) number. These settings allow clinicians to customize treatment parameters for different skin types, depths, and procedural requirements. The exact FEI numbers are listed in the device specifications for reference.
What type of sterilization is required for the Mosaic 3D Surgical Laser?
The Mosaic 3D Surgical Laser is compatible with standard clinical sterilization methods, though the manufacturer does not specify a preferred method in the provided data. Common sterilization techniques for reusable surgical lasers include steam sterilization (autoclave), ethylene oxide, or hydrogen peroxide gas plasma. Always follow the manufacturer’s instructions and facility protocols to ensure proper sterilization and device integrity.
Where can I find more information about the regulatory approval of this device?
The Mosaic 3D Surgical Laser holds FDA clearance under the 510(k) pathway, with clearance number K233550. It is classified as a Class II medical device under FDA regulation 878.4810 and is substantially equivalent to predicate devices. For detailed regulatory documentation, including the full 510(k) submission, you may contact Lutronic Aesthetic at the provided address or refer to the FDA’s OpenFDA database using the listed registration numbers.