Lucas Plus (K230340)
510(k) K230340
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK230340 | Date4 May 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Lucas Plus
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Lucas Plus (K230340) is a Q-switched Nd:YAG laser system designed for dermatological applications. It is classified as a laser device intended for skin pigmentation treatment and skin toning procedures. The device delivers controlled laser energy to target specific skin concerns, including hyperpigmentation and uneven skin tone. Its design aligns with medical-grade laser systems used in plastic surgery and aesthetic dermatology.
The Lucas Plus is supplied by Amt Engineering Co., Ltd. and is intended for use in clinical or professional dermatological settings. It is regulated under FDA 510(k) clearance (K230340) and falls under the General, Plastic Surgery advisory committee category. The device is not explicitly stated as single-use or reusable, sterility, or MRI safety in the provided data. Storage and operational details are not specified beyond its classification as a medical laser system.
Other devices from Amt Engineering Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the Lucas Plus laser system used for?
The Lucas Plus (K230340) is a Q-switched Nd:YAG laser designed specifically for dermatological applications. It is intended to treat skin pigmentation concerns, such as hyperpigmentation and uneven skin tone, by delivering controlled laser energy to targeted areas. This makes it suitable for clinical or professional dermatological settings, including plastic surgery and aesthetic dermatology procedures.
How is the Lucas Plus laser system supplied and intended for use?
The Lucas Plus is supplied by Amt Engineering Co., Ltd. and is classified as a medical-grade laser system. It is intended exclusively for use in clinical or professional dermatological settings, where trained practitioners can administer treatments for skin pigmentation and toning. The device is not intended for home or non-professional use.
Is the Lucas Plus laser system single-use or reusable?
The provided data does not explicitly state whether the Lucas Plus laser system is single-use or reusable. For clinical use, it is critical to follow manufacturer guidelines and facility protocols to ensure proper maintenance, cleaning, and sterilization if reuse is intended. Always verify with Amt Engineering Co., Ltd. for specific operational instructions.
What regulatory clearance does the Lucas Plus laser system hold?
The Lucas Plus (K230340) holds FDA 510(k) clearance, which means it has been determined to be substantially equivalent to a legally marketed device. This clearance falls under the General, Plastic Surgery advisory committee category and was granted on May 4, 2023. The device is regulated under the product code GEX.
What should be considered for storage and maintenance of the Lucas Plus?
While specific storage instructions are not detailed in the provided data, as a medical laser system, the Lucas Plus should be stored in a clean, controlled environment to protect it from dust, moisture, and physical damage. Follow manufacturer recommendations for calibration, maintenance, and operational checks to ensure optimal performance and safety. Always consult Amt Engineering Co., Ltd. for detailed guidelines.