PicoAlex
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- PICOALEX EUDAMEDFDA UDI
- Generic Name
- Dermatological solid-state laser system FDA UDI
- Device Name
- Alexandrite laser System FDA UDI
- Model / Reference
- PICOALEX EUDAMEDFDA UDIAlexandrite Laser System EUDAMED
- Description
- Alexandrite laser System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800022304412 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800022304412 EUDAMED
- 510(k) Number
- FDA Product Code
- GEX FDA 510(k)FDA UDI
- EMDN Code
- Z12011017 NEODYMIUM SURGICAL LASER EUDAMED
- GMDN Term
- Dermatological solid-state laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)FDA UDI
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The PicoAlex is a pulsed dye laser device (Product Code GEX) designed for dermatological and plastic surgery applications. It delivers controlled picosecond laser pulses to target vascular lesions, pigmentation, and skin rejuvenation with precision, leveraging advanced photothermolysis technology.
Supplied as a reusable medical instrument, the PicoAlex weighs approximately 100 kg and is intended for use in clinical settings. It has received FDA 510(k) clearance under the Traditional pathway and complies with the Medical Device Directive (MDD). Storage and handling follow standard sterile or non-sterile medical device protocols as specified by the manufacturer.
Frequently asked questions
What clinical applications is the PicoAlex intended for, and how does it achieve its effects?
The PicoAlex is designed for dermatological and plastic surgery procedures, specifically targeting vascular lesions, pigmentation issues, and skin rejuvenation. It uses pulsed dye laser technology to deliver precise picosecond pulses, which selectively target and break down unwanted tissue while preserving surrounding healthy skin. This advanced photothermolysis approach minimizes collateral damage, making it suitable for procedures like port-wine stain removal, tattoo reduction, and facial rejuvenation.
Is the PicoAlex a single-use device, or is it meant for repeated clinical use?
The PicoAlex is supplied as a reusable medical instrument, weighing approximately 100 kg, and is intended for use in clinical settings. Unlike disposable devices, it is built for repeated use in professional environments like dermatology clinics or surgical centers, with maintenance and cleaning protocols provided by the manufacturer.
How is the PicoAlex regulated, and what does its clearance status mean for buyers?
The PicoAlex has received FDA 510(k) clearance under the Traditional pathway, meaning it has been deemed *substantially equivalent* to a legally marketed predicate device. It also complies with the Medical Device Directive (MDD) in the EU. This clearance indicates that the device meets regulatory standards for safety and effectiveness as determined by the FDA’s review process, though buyers should verify local compliance requirements.
What storage and handling considerations should clinicians follow for the PicoAlex?
Since the PicoAlex is a reusable medical instrument, storage and handling must adhere to standard protocols for non-sterile or sterile reusable devices, depending on the manufacturer’s guidelines. This typically includes proper cleaning, disinfection, and maintenance to ensure device integrity and infection control. The manufacturer’s instructions should be consulted for specific storage conditions, such as temperature or environmental controls, to preserve functionality.
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: K243957 FDA 510 (k) - PICOALEX | Wontech Co., Ltd., Picoalex - WONTECH ASIA, 원텍 wontech, PICOALEX (K243957) — FDA 510 (k) | Innolitics, PICOALEX — FDA 510 (k) K243957 | MedTracker - aiqixie.com
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 | K243957 | Class II | Active |
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Manufacturer
- Manufacturer
- Wontech Co., Ltd
- FDA Applicant
- Wontech Co., Ltd.
Sources (3)
- FDA 510(k) K243957 24 fields · synced Sep 18, 2026
- FDA UDI e03dad7c-3079-475e-af21-8d6b3faea1a6 34 fields · synced May 30, 2026
- EUDAMED dd19bcf3-c601-4bf8-b3d1-382cc1ded7bb 61 fields · synced Jul 13, 2026