Q-Switched Nd:YAG Laser (SHE-LSP101-1)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250936 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 Q-Switched Nd:YAG Laser (SHE-LSP101-1) is a laser device used in general and plastic surgery applications. It is a substantially equivalent device cleared through the FDA 510(k) process under product code GEX.
This device is supplied by Beijing Sano Laser S&T Development Co., Ltd and was cleared via the traditional 510(k) pathway with K number K250936. It received FDA clearance on June 12, 2025, following submission on March 28, 2025.
Frequently asked questions
What is the Q-Switched Nd:YAG Laser (SHE-LSP101-1) used for?
The Q-Switched Nd:YAG Laser (SHE-LSP101-1) is a laser device used in general and plastic surgery applications, as stated in its description, making it suitable for procedures requiring precise laser energy delivery in those clinical fields.
How is the Q-Switched Nd:YAG Laser (SHE-LSP101-1) supplied and by whom?
The device is supplied by Beijing Sano Laser S&T Development Co., Ltd, the manufacturer listed in the device data, and is provided as a complete laser system for clinical use in general and plastic surgery settings.
What regulatory pathway was used to clear the Q-Switched Nd:YAG Laser (SHE-LSP101-1)?
The device was cleared through the FDA 510(k) process under the traditional pathway, as indicated by the clearance_type field and the K number K250936, with a decision date of June 12, 2025, following submission on March 28, 2025.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250936 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Sano Laser S&T Development Co., Ltd
- FDA Applicant
- Beijing Sano Laser S&T Development Co.,Ltd
Sources (1)
- FDA 510(k) K250936 24 fields · synced Sep 21, 2026