Intense Pulsed Light Treatment System LK-PT
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242440 FDA 510(k)
- FDA Product Code
- ONF 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 Intense Pulsed Light Treatment System LK-PT is a Powered Light-Based Non-Laser Surgical Instrument with Thermal Effect, classified under product code ONF. This device delivers controlled pulses of broad-spectrum light to target skin conditions, promoting tissue remodeling, pigment reduction, or vascular lesion treatment through thermal effects. It operates within a defined wavelength range to achieve therapeutic outcomes without laser-based precision, making it suitable for cosmetic and dermatological applications.
The system is intended for single-use or reusable settings, depending on configuration, and is regulated under 21 CFR 878.4810 with FDA 510(k) clearance (K242440). It is designed for use in sterile or non-sterile environments, depending on the procedure, and may require specific MRI safety considerations as outlined in its technical documentation. Multiple registration numbers (e.g., 3006985163) correspond to its global distribution, though regulatory compliance varies by jurisdiction. Storage and handling follow manufacturer guidelines to maintain performance and safety.
Frequently asked questions
What is the LK-PT Intense Pulsed Light Treatment System used for?
The LK-PT system is designed to treat skin conditions through controlled pulses of broad-spectrum light, targeting tissue remodeling, pigment reduction, and vascular lesions. Unlike laser-based devices, it achieves therapeutic effects through thermal mechanisms without the precision of laser wavelengths. This makes it suitable for cosmetic and dermatological applications, such as improving skin texture, reducing sunspots, or addressing minor vascular issues like broken capillaries.
How is the LK-PT system supplied, and is it single-use or reusable?
The LK-PT system can be configured for either single-use or reusable applications, depending on the clinical setting and procedure requirements. Single-use components may be specified for sterile environments to minimize cross-contamination risks, while reusable parts would require strict cleaning, sterilization, and maintenance protocols as outlined in the manufacturer’s guidelines. Always verify the intended use and handling instructions for your specific configuration.
Does the LK-PT system require sterile handling, and where can it be used?
The LK-PT system can be used in both sterile and non-sterile environments, depending on the procedure being performed. For example, treatments targeting open wounds or invasive procedures would necessitate sterile conditions, while non-invasive cosmetic applications may not require sterility. Always follow the manufacturer’s instructions and local clinical protocols to ensure proper use and safety.
What regulatory approvals does the LK-PT system hold, and how does it comply with global standards?
The LK-PT system holds FDA 510(k) clearance (K242440) under product code ONF, indicating it is classified as a Powered Light-Based Non-Laser Surgical Instrument with Thermal Effect. While it is FDA-cleared, regulatory compliance varies by jurisdiction. The system is regulated under 21 CFR 878.4810 in the U.S., and multiple registration numbers (e.g., 3006985163) correspond to its global distribution. Always consult local health authorities or the manufacturer for jurisdiction-specific requirements.
Are there specific storage or handling guidelines for the LK-PT system?
The LK-PT system’s storage and handling must adhere to the manufacturer’s guidelines to maintain performance and safety. This includes protecting the device from physical damage, extreme temperatures, and contamination. For reusable components, proper cleaning and sterilization protocols are critical to prevent cross-infection. Always refer to the included technical documentation or contact Nanjing Bestview Laser S&T Co., Ltd. for detailed instructions tailored to your configuration.
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: Über uns | INTENSE, Intense Pulsed Light Treatment System (LK-PT), K242440 FDA 510(k) - Intense Pulsed Light Treatment System (..., Intense Pulsed Light Treatment System (LK-PT) — FDA K242440
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242440 | Class II | Active |
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Manufacturer
- Manufacturer
- Nanjing Bestview Laser S&T Co., Ltd.
Sources (1)
- FDA 510(k) K242440 24 fields · synced Oct 1, 2026