Identifiers
- 510(k) Number
- K163196 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 ACTION II Laser System is an Er:YAG laser device (2940 nm wavelength) classified under general and plastic surgery applications. It is designed for dermatological procedures, including skin resurfacing, ablation, and fractional treatments, as well as gynecological applications when used with compatible handpieces. The system operates in multiple pulse modes, including normal, long-pulse, and fractional, to address various clinical needs with precision.
The ACTION II Laser System is supplied as a reusable medical device and is intended for use in clinical settings by trained professionals. It is not sterile upon delivery and requires proper cleaning and maintenance as per manufacturer guidelines. The device is regulated under FDA 510(k) clearance (K163196) and is classified under product code GEX. No specific MRI safety information is provided, and storage conditions should adhere to the manufacturer’s instructions to ensure optimal performance and safety.
Frequently asked questions
What clinical applications is the ACTION II Laser System primarily used for, and how does its wavelength support those treatments?
The ACTION II Laser System is designed for dermatological procedures like skin resurfacing, ablation, and fractional treatments, as well as gynecological applications when paired with compatible handpieces. Its 2940 nm Er:YAG wavelength is effective for precise tissue removal and resurfacing, making it suitable for procedures requiring controlled ablation of skin layers or fractional treatment for skin rejuvenation. The multiple pulse modes (normal, long-pulse, and fractional) allow clinicians to tailor the treatment to specific clinical needs.
Is the ACTION II Laser System intended for single-use or reusable use, and what maintenance is required?
The ACTION II Laser System is a reusable medical device, meaning it is not designed for single-use. After each procedure, it must be thoroughly cleaned and maintained according to the manufacturer’s guidelines to ensure safety and performance. The device is not sterile upon delivery, so proper sterilization protocols must be followed before clinical use.
What storage conditions should be followed for the ACTION II Laser System to maintain its performance?
The ACTION II Laser System requires storage conditions that align with the manufacturer’s instructions to preserve its functionality and safety. While specific details like temperature or environmental controls aren’t provided, adhering to Lutronic Corporation’s guidelines—likely including protection from moisture, dust, and physical damage—is essential. Improper storage could compromise the device’s precision or longevity.
How does the ACTION II Laser System differ from other laser systems in terms of its regulatory pathway?
The ACTION II Laser System follows an FDA 510(k) clearance pathway, classified under product code GEX (General, Plastic Surgery) and determined to be *substantially equivalent* to a predicate device. This means its safety and effectiveness were compared to an existing laser system already on the market, ensuring it meets regulatory standards for dermatological and gynecological laser applications. The clearance (K163196) reflects its compliance with FDA requirements for reusable laser devices in clinical settings.
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: ACTION II™ - Dermatology laser by Lutronic | MedicalExpo, Lutronic Action II Er:YAG Laser - Global Faster Tech, Lutronic Action II Erbium Laser with Many Applications
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163196 | Class II | Active |
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Manufacturer
- Manufacturer
- Lutronic Corporation
Sources (1)
- FDA 510(k) K163196 24 fields · synced Sep 20, 2026