Youlaser Co2 Laser System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111592 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 Youlaser CO₂ Laser System is a fractional resurfacing and dermatologic surgery device classified under the General, Plastic Surgery advisory committee category. It employs a carbon dioxide (CO₂) laser at 10600 nm wavelength, delivering precise tissue ablation and skin remodeling for aesthetic and reconstructive procedures. The system is designed for controlled energy delivery, enabling treatments such as skin resurfacing, scar revision, and dermatological corrections. Its dual-source capability integrates CO₂ with fiber laser technology for enhanced therapeutic outcomes.
The Youlaser CO₂ Laser System is supplied as a medical device intended for use in clinical settings, including dermatology and plastic surgery offices. It is regulated under FDA 510K clearance and MDD compliance, with a Traditional review pathway. The device is not specified as single-use or reusable in the provided data, though its design suggests it requires maintenance and calibration. No details on MRI safety or sterility are provided, and storage conditions are not specified beyond standard medical device handling. The system is authorized under K111592 and falls under the GEX product code.
Frequently asked questions
What types of medical procedures is the Youlaser CO₂ Laser System primarily used for in clinical settings?
The Youlaser CO₂ Laser System is designed for fractional resurfacing and dermatologic surgery, including skin resurfacing, scar revision, and dermatological corrections. Its CO₂ laser technology at 10600 nm wavelength enables precise tissue ablation and skin remodeling, making it suitable for aesthetic and reconstructive treatments in dermatology and plastic surgery offices.
Is the Youlaser CO₂ Laser System intended for single-use or repeated use in a clinical environment?
The provided data does not explicitly state whether the Youlaser CO₂ Laser System is single-use or reusable. However, given its design as a medical device requiring maintenance and calibration—common for reusable systems—it is likely intended for repeated use in clinical settings. Always follow manufacturer guidelines for proper cleaning, sterilization, and upkeep.
What regulatory pathways does the Youlaser CO₂ Laser System follow for approval and compliance?
The Youlaser CO₂ Laser System is cleared under the FDA’s 510(k) pathway with a Traditional review, classified under the General, Plastic Surgery advisory committee (SU). It also complies with the Medical Device Directive (MDD) and holds the product code GEX. The system was submitted under K111592 and received clearance on August 25, 2011.
Does the Youlaser CO₂ Laser System combine multiple laser technologies, and if so, how does this benefit treatment outcomes?
Yes, the Youlaser CO₂ Laser System features dual-source capability, integrating CO₂ laser technology with fiber laser technology. This combination enhances therapeutic outcomes by providing versatility in tissue ablation and skin remodeling, allowing clinicians to tailor treatments more effectively for procedures like resurfacing and scar revision.
What should clinicians consider regarding the storage and handling of the Youlaser CO₂ Laser System?
The provided data does not specify exact storage conditions beyond standard medical device handling. Clinicians should follow manufacturer-recommended guidelines for environmental storage (e.g., temperature, humidity) and ensure proper maintenance to preserve performance. Since the system is not labeled as sterile or MRI-safe, additional precautions may apply depending on clinical workflows.
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. Sources consulted: Youlaser Prime - Aesthetic & Cosmetic Lasers | Quanta System, Youlaser MT - Aesthetic & Cosmetic Lasers | Quanta System, Youlaser Series CO₂ Laser Systems for Skin Resurfacing - Astanza, Quanta System YouLaser MT - Swastika Medical
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K111592 | Class II | Active |
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Manufacturer
- Manufacturer
- Quanta System Spa
Sources (2)
- FDA 510(k) K111592 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026