← Back to catalogue

Litho Laser System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K091909

by Quanta System Spa

Identifiers

510(k) Number
K091909 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Litho Laser System is a laser device classified under the nomenclature for laser surgical instruments (GEX product code), designed for tissue ablation and resurfacing procedures. It emits controlled laser energy to precisely remove or modify skin layers, typically used in dermatological and plastic surgery applications such as skin rejuvenation, tattoo removal, or scar revision.

This system is supplied as a reusable medical device, intended for use in clinical settings such as surgical suites or dermatology clinics. It requires proper sterilization and maintenance per manufacturer guidelines, with no specific MRI safety restrictions noted. The device holds FDA 510(k) clearance under the Medical Device Directive (MDD) and is regulated as a Class II device in the European Union. Authorisation details include K-number K091909 and submission to the General, Plastic Surgery advisory committee.

Frequently asked questions

Is the Litho Laser System intended for use in outpatient clinics or only in surgical suites?

The Litho Laser System is designed for clinical settings like surgical suites or dermatology clinics, which include both inpatient and outpatient environments. Its use in dermatological and plastic surgery procedures—such as skin rejuvenation or scar revision—aligns with the flexibility of outpatient clinics where such treatments are commonly performed. Always follow facility-specific protocols for laser safety and sterilization.

How is the Litho Laser System sterilized, and can it be reused?

The Litho Laser System is explicitly labeled as a reusable medical device, meaning it must undergo proper sterilization between uses as per the manufacturer’s guidelines. Reusability is standard for high-end laser systems to ensure cost-effectiveness and precision, but sterilization protocols (e.g., autoclave or chemical sterilization) must be strictly adhered to avoid contamination or damage to the device.

What types of dermatological procedures is the Litho Laser System primarily used for?

The Litho Laser System is engineered for tissue ablation and resurfacing, making it suitable for dermatological and plastic surgery applications like skin rejuvenation, tattoo removal, and scar revision. Its controlled laser energy allows for precise modification of skin layers, targeting common cosmetic or functional concerns in these fields. Always consult the manufacturer’s instructions for specific procedural guidelines.

Does the Litho Laser System have any restrictions on use in facilities with MRI equipment?

The Litho Laser System does not have any noted MRI safety restrictions in the provided documentation. However, laser systems generally require careful handling near MRI environments due to potential electromagnetic interference or safety hazards. Always verify compatibility with your facility’s MRI protocols and consult the manufacturer for specific precautions, even if none are explicitly listed.

What regulatory pathways does the Litho Laser System follow in the U.S. and Europe?

In the U.S., the Litho Laser System holds FDA 510(k) clearance under the Medical Device Directive (MDD) framework, classified as a Class II device. It was reviewed by the General, Plastic Surgery advisory committee (SU) and granted a substantially equivalent (SESE) decision in 2009. In Europe, it is regulated under the Medical Device Directive (MDD) as a Class II device, though specific CE marking details are not provided in the data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Quanta System Spa

Sources (2)

  • FDA 510(k) K091909 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026