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Intense Pulsed Light Equipment

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220385

by Beijing Globalipl Development Co., Ltd.

Identifiers

510(k) Number
K220385 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)

This device is a Powered Light-Based Non-Laser Surgical Instrument With Thermal Effect, classified as a Class II medical device. It delivers controlled pulses of broad-spectrum light to target skin conditions, promoting collagen remodeling, pigment reduction, or vascular lesion treatment through thermal effects on the dermis.

Intended for use in clinical settings such as dermatology and plastic surgery, the device operates as a reusable system with disposable handpieces or filters. It is not MRI-compatible and requires proper storage in a clean, dry environment to maintain performance. Authorized under FDA 510(k) clearance and MDD compliance, it adheres to regulatory standards for powered light-based therapies, with multiple registration numbers listed under Chinese medical device regulations.

Frequently asked questions

What clinical specialties is this device primarily intended for, and how does it work?

This device is designed for use in dermatology and plastic surgery clinics. It delivers controlled pulses of broad-spectrum light to target skin conditions like pigment reduction, vascular lesions, or collagen remodeling. The thermal effects generated by the light interact with the dermis to achieve these cosmetic and therapeutic outcomes.

Is the device itself reusable, or are there single-use components involved?

The main device system is reusable, but it operates with disposable handpieces or filters. This design ensures hygiene and reduces cross-contamination risks between patients while maintaining the device’s performance.

How should the device be stored to maintain its performance and safety?

The device must be stored in a clean, dry environment to preserve its functionality. Since it is not MRI-compatible, it should also be kept away from magnetic fields. Proper storage conditions are critical to ensure consistent performance and longevity.

What regulatory pathways has this device undergone, and what does that mean for its use?

The device has been authorized under both FDA 510(k) clearance and the Medical Device Directive (MDD) in the EU, confirming it meets regulatory standards for powered light-based therapies. This means it has been evaluated for safety and effectiveness in its intended clinical applications, such as dermatology and plastic surgery.

Are there multiple models or configurations available for this device?

While the provided data does not specify exact model variations, the device is classified under the product code ONF (Non-Functional) and includes multiple registration numbers in Chinese regulations, suggesting potential variations in specifications or configurations. However, the core functionality remains consistent across applications for dermatological and plastic surgery treatments.

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
Beijing Globalipl Development Co., Ltd.

Sources (2)

  • FDA 510(k) K220385 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026