PicoLO Nd:YAG Picosecond Laser System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K203491 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 PicoLO Nd:YAG Picosecond Laser System is a picosecond laser device designed for non-ablative skin resurfacing and tissue remodeling. It emits ultra-short pulses of near-infrared laser energy to target chromophores such as melanin, hemoglobin, and collagen, promoting skin rejuvenation and treating conditions like pigmentation irregularities, vascular lesions, and acne scars. The system leverages picosecond technology to deliver precise, controlled energy for enhanced safety and efficacy in cosmetic and dermatological applications. Its design aligns with the classification of a laser system intended for aesthetic and therapeutic skin treatments.
This device is supplied as a standalone laser system intended for use in clinical or professional settings by trained operators. It is not classified as single-use or sterile but requires proper maintenance and cleaning per manufacturer guidelines to ensure performance and safety. The system is FDA-cleared under a 510(k) submission (K203491) as substantially equivalent to a predicate device, with advisory review by the Skin and Soft Tissue Devices (SU) committee. Storage and operational use must comply with regulatory and facility-specific protocols, including adherence to laser safety standards and environmental controls.
Frequently asked questions
What is the PicoLO Nd:YAG Picosecond Laser System used for?
The PicoLO Nd:YAG Picosecond Laser System is designed for non-ablative skin resurfacing and tissue remodeling. It emits ultra-short pulses of near-infrared laser energy to precisely target chromophores like melanin, hemoglobin, and collagen. This promotes skin rejuvenation and helps treat conditions such as pigmentation irregularities, vascular lesions, and acne scars. The technology ensures controlled energy delivery for enhanced safety and efficacy in cosmetic and dermatological applications.
Is the PicoLO Nd:YAG Picosecond Laser System single-use or reusable?
The PicoLO Nd:YAG Picosecond Laser System is not classified as single-use. It is intended for use in clinical or professional settings by trained operators and requires proper maintenance and cleaning as outlined by the manufacturer. This ensures optimal performance and safety during repeated use, adhering to regulatory and facility-specific protocols.
How is the PicoLO Nd:YAG Picosecond Laser System supplied?
The PicoLO Nd:YAG Picosecond Laser System is supplied as a standalone laser system. It is not sterile and is intended for use in controlled environments where trained professionals can operate it. The system must be maintained and cleaned according to manufacturer guidelines to ensure its functionality and safety.
What regulatory approval does the PicoLO Nd:YAG Picosecond Laser System have?
The PicoLO Nd:YAG Picosecond Laser System has received FDA clearance under a 510(k) submission (K203491). The clearance was granted as substantially equivalent to a predicate device, with advisory review by the Skin and Soft Tissue Devices (SU) committee. This approval supports its use for aesthetic and therapeutic skin treatments in regulated clinical settings.
What safety and storage guidelines apply to the PicoLO Nd:YAG Picosecond Laser System?
The PicoLO Nd:YAG Picosecond Laser System must be stored and operated in compliance with regulatory and facility-specific protocols. This includes adherence to laser safety standards and environmental controls to ensure safe use. Proper maintenance, cleaning, and handling are critical to maintaining performance and safety, as outlined by the manufacturer’s 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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203491 | Class II | Active |
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Manufacturer
- Manufacturer
- Laseroptek Co., Ltd
- FDA Applicant
- Laseroptek Co., Ltd.
Sources (1)
- FDA 510(k) K203491 24 fields · synced Oct 1, 2026