Nobleen Long Pulsed Alexandrite & Nd:YAG Laser System
510(k) K182663
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK182663 | Date30 Nov 2018 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- GEX
- FDA applicant
- Finemec Co., Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Nobleen Long Pulsed Alexandrite & Nd:YAG Laser System is a dual-wavelength laser device classified under the General, Plastic Surgery category (Product Code: GEX). It combines long-pulsed Alexandrite (755 nm) and Nd:YAG (1064 nm) laser technologies for targeted tissue interaction, primarily used in cosmetic and dermatological procedures. The device delivers controlled energy to achieve selective photothermolysis, enabling applications such as hair reduction and skin rejuvenation. Its dual-wavelength design allows for versatility in treating varying skin types and pigmentation levels, adhering to established laser safety protocols.
This system is supplied as a medical device and is intended for professional use only in clinical or aesthetic settings. The device is not single-use and requires proper maintenance, calibration, and adherence to manufacturer guidelines for safe operation. It is not MRI-compatible and must be stored in a controlled environment to preserve performance and sterility. Authorized for use under FDA 510(k) clearance (K182663) and MDD compliance, the system is regulated as a Class IIa medical device in accordance with applicable standards.
Other devices from FineMEC Co., Ltd
Questions
AI-generated answers, 20 Sep 2026
What types of procedures is the Nobleen Long Pulsed Alexandrite & Nd:YAG Laser System primarily used for in clinical settings?
The Nobleen system is designed for cosmetic and dermatological applications, specifically targeting hair reduction and skin rejuvenation. Its dual-wavelength technology (Alexandrite 755 nm and Nd:YAG 1064 nm) allows for selective photothermolysis, making it versatile for treating varying skin types and pigmentation levels in professional settings like clinics or aesthetic practices.
Is the Nobleen Long Pulsed Alexandrite & Nd:YAG Laser System intended for single-use, or does it require maintenance and recalibration?
The Nobleen system is not single-use and is built for professional, repeated use in controlled environments. It requires regular maintenance, calibration, and adherence to manufacturer guidelines to ensure safe and effective operation, as outlined in its design specifications.
How should the Nobleen system be stored to maintain its performance and safety?
The device must be stored in a controlled environment to preserve performance and sterility. Since it is not MRI-compatible, it should also be kept away from magnetic fields or imaging equipment that could interfere with its operation.
What regulatory pathways has the Nobleen Long Pulsed Alexandrite & Nd:YAG Laser System followed for approval?
The Nobleen system has obtained FDA clearance under the 510(k) pathway (K182663) and complies with the Medical Device Directive (MDD). It is classified as a Class IIa medical device, adhering to applicable standards for general plastic surgery applications.