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PicoSure Workstation

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K210226

by Cynosure, LLC

Identifiers

510(k) Number
K210226 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 PicoSure Workstation is a picosecond laser device designed for non-ablative skin resurfacing and hair removal. It delivers ultra-short pulsed laser energy to target pigmentation, tattoos, vascular lesions, and hair follicles while preserving surrounding tissue integrity.

This device is intended for use in clinical settings by trained professionals and is supplied as a reusable workstation with disposable handpieces. It is not sterile and requires proper cleaning and maintenance as per manufacturer instructions. The PicoSure Workstation holds FDA 510(k) clearance under the General, Plastic Surgery advisory committee and complies with the Medical Device Directive (MDD).

Frequently asked questions

What clinical conditions is the PicoSure Workstation primarily used to treat, and how does it differ from traditional laser treatments?

The PicoSure Workstation is designed for non-ablative skin resurfacing and hair removal, targeting pigmentation, tattoos, vascular lesions, and hair follicles. Unlike traditional ablative lasers that remove layers of skin, this device delivers ultra-short pulsed laser energy to break down targeted tissues (like pigment or hair) while minimizing damage to surrounding healthy tissue. This approach preserves skin integrity and reduces downtime, making it suitable for sensitive areas or patients seeking faster recovery.

Is the PicoSure Workstation meant for single-use or reusable applications, and what does that mean for maintenance?

The PicoSure Workstation itself is a reusable device, but it is supplied with disposable handpieces for each patient session. This design ensures hygiene and reduces cross-contamination risks. After use, the reusable components must be thoroughly cleaned and maintained according to the manufacturer’s instructions to ensure proper functionality and longevity.

How is the PicoSure Workstation regulated, and what does that mean for clinicians using it?

The PicoSure Workstation holds FDA 510(k) clearance under the General, Plastic Surgery advisory committee, meaning it has been deemed substantially equivalent to a legally marketed device. Clinicians using it must follow the manufacturer’s guidelines for safe operation, training, and maintenance. Compliance with the Medical Device Directive (MDD) also applies, ensuring adherence to European regulatory standards if used outside the U.S.

Are there different models or sizes available for the PicoSure Workstation, and how would a clinician choose the right one?

The provided data does not specify distinct models or sizes for the PicoSure Workstation, but it is designed as a versatile workstation for clinical use. Clinicians should refer to the manufacturer’s documentation for any available configurations or accessories. The choice may depend on practice needs, such as treatment area size or specific patient populations, but no variations are listed in the regulatory details.

Since the PicoSure Workstation is not sterile, what precautions should be taken during use to ensure patient safety?

Because the PicoSure Workstation is not sterile, clinicians must use disposable handpieces for each patient session to prevent contamination. The reusable components must be cleaned and maintained rigorously following the manufacturer’s instructions to avoid cross-infection. Proper sterilization of any accessories or surfaces in contact with patients is also critical, as outlined in the device’s operational guidelines.

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

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Manufacturer

Manufacturer
Cynosure, LLC

Sources (2)

  • FDA 510(k) K210226 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026