Nd:YAG Laser Therapy Systems
by Sanhe Meditech Co., Ltd. 510(k)
Active
510(k) K260375
Overview
The Nd:YAG Laser Therapy Systems are classified as Laser Therapy Devices (Device Type: GEX) designed for non-invasive tissue treatment. These systems utilize neodymium-doped yttrium aluminum garnet (Nd:YAG) lasers to deliver focused energy for procedures such as vascular lesion removal, pigmentation treatment, and dermatological corrections. Their precise wavelength and power output enable controlled thermal effects on targeted tissues, minimizing collateral damage to surrounding areas.
These systems are supplied as medical devices and are intended for single-use or reusable applications, depending on manufacturer specifications. They are regulated under FDA 510(k) clearance (K260375) and fall under the General, Plastic Surgery advisory committee classification. Compliance with sterility standards and MRI safety guidelines must be verified per manufacturer instructions, with storage conditions typically requiring protection from moisture and extreme temperatures. No additional regulatory status beyond the stated clearance is implied.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK260375 | Date31 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
Other devices from Sanhe Meditech Co., Ltd.
Questions
What types of medical procedures can the Nd:YAG Laser Therapy Systems be used for according to their design?
The Nd:YAG Laser Therapy Systems are designed for non-invasive tissue treatments, specifically for procedures like vascular lesion removal, pigmentation treatment, and dermatological corrections. The precise wavelength and power output of the Nd:YAG laser allow for controlled thermal effects on targeted tissues, helping to minimize damage to surrounding areas during these treatments.
Are the Nd:YAG Laser Therapy Systems intended for single-use or reusable applications, and what should I consider when deciding?
The Nd:YAG Laser Therapy Systems can be used for either single-use or reusable applications, depending on the manufacturer’s specifications. When deciding, you should verify the manufacturer’s instructions for sterility standards, maintenance protocols, and compliance with MRI safety guidelines. Additionally, ensure proper storage conditions—protection from moisture and extreme temperatures—to maintain device integrity and performance.
How is the regulatory status of the Nd:YAG Laser Therapy Systems determined, and what does that mean for purchasing or using them?
The Nd:YAG Laser Therapy Systems are regulated under the FDA’s 510(k) clearance process, specifically with clearance number K260375. This classification means the device has been determined to be *substantially equivalent* to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness requirements. Purchasers or users should confirm compliance with the manufacturer’s instructions for sterility, maintenance, and storage to align with regulatory expectations.
What storage conditions should I follow to ensure the Nd:YAG Laser Therapy Systems remain effective and safe for use?
The manufacturer recommends storing the Nd:YAG Laser Therapy Systems in a way that protects them from moisture and extreme temperatures. Proper storage is critical to maintaining device performance, sterility (if applicable), and compliance with MRI safety guidelines. Always refer to the manufacturer’s instructions for specific storage recommendations, as conditions may vary depending on whether the system is intended for single-use or reusable applications.
How can I confirm whether a specific model of the Nd:YAG Laser Therapy Systems is compatible with MRI environments?
Compatibility with MRI environments must be verified per the manufacturer’s instructions, as the Nd:YAG Laser Therapy Systems may or may not be MRI-safe depending on their design and materials. Check the manufacturer’s documentation or contact their technical support to confirm whether the specific model you are considering meets MRI safety standards before use in such environments.