Cynosure Acclaim Dermatology Laser
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K011828 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 Cynosure Acclaim Dermatology Laser is a medical device classified as a laser system for dermatological use, designed for the treatment of benign cutaneous vascular lesions and hair removal. It employs advanced laser technology to target specific tissue types with precision, delivering controlled energy to achieve clinical outcomes. The device incorporates multiple laser wavelengths, including alexandrite, Nd:YAG, and picosecond modalities, to address various dermatological indications. Its design aligns with FDA-recognized standards for safety and efficacy in aesthetic and medical dermatology procedures.
This laser system is intended for use in clinical settings by trained professionals, such as dermatologists and plastic surgeons. It is supplied as a reusable medical device, requiring proper maintenance and calibration to ensure consistent performance. The device is not sterile at shipment but is designed for use in controlled environments where sterility protocols are followed. No specific MRI safety classification is stated in the regulatory data, and its use must comply with local regulatory requirements, including the FDA 510(k) clearance (K011828).
Frequently asked questions
What dermatological conditions is the Cynosure Acclaim Dermatology Laser designed to treat?
The Cynosure Acclaim Dermatology Laser is specifically designed for the treatment of benign cutaneous vascular lesions and hair removal. Its advanced laser technology, including alexandrite, Nd:YAG, and picosecond modalities, allows for precise targeting of specific tissue types to achieve clinical outcomes in these areas. This makes it suitable for procedures like vascular lesion ablation and laser hair reduction under professional supervision.
Is the Cynosure Acclaim Dermatology Laser a single-use or reusable device?
The Cynosure Acclaim Dermatology Laser is a reusable medical device. It is not sterile at shipment and is intended for use in controlled clinical environments where proper sterility protocols are followed. Reusability requires adherence to maintenance and calibration procedures to ensure consistent performance and safety during dermatological procedures.
What types of laser wavelengths does the Cynosure Acclaim Dermatology Laser use?
The device incorporates multiple laser wavelengths, including alexandrite, Nd:YAG, and picosecond modalities. These wavelengths are selected to target different tissue types with precision, enabling effective treatment of vascular lesions and hair removal. The versatility of these modalities allows clinicians to tailor the procedure to specific patient needs.
Who is authorized to use the Cynosure Acclaim Dermatology Laser?
The Cynosure Acclaim Dermatology Laser is intended for use by trained professionals, such as dermatologists and plastic surgeons, in clinical settings. Its design and functionality align with FDA-recognized standards for safety and efficacy in dermatological procedures, ensuring it is only operated by qualified personnel.
What maintenance is required for the Cynosure Acclaim Dermatology Laser?
As a reusable device, the Cynosure Acclaim Dermatology Laser requires proper maintenance and calibration to ensure optimal performance and safety. Regular upkeep, including cleaning and servicing as recommended by the manufacturer, is essential to maintain its precision and reliability for dermatological treatments. Follow the manufacturer’s guidelines to extend the device’s lifespan and ensure consistent clinical outcomes.
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: Cynosure Lutronic - Enhance your practice. Expand your services., Medizinische Laser | Ästhetische Lasergeräte | Cynosure Lutronic, CYNOSURE ACCLAIM DERMATOLOGY LASER (K011828) — FDA 510 (k) | Innolitics, Cynosure Laser | Medical Aesthetic Laser Technology - Precision ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011828 | Class II | Active |
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Manufacturer
- Manufacturer
- Cynosure, Inc.
Sources (1)
- FDA 510(k) K011828 24 fields · synced Oct 1, 2026