Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)— 510(k) K253828
Substantially EquivalentBeijing HuaCheng Taike Technology Co., Ltd.
FDA 510(k) clearance K253828 for Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP), Substantially Equivalent on 2026-02-27. Applicant: Beijing HuaCheng Taike Technology Co., Ltd.. Device class: 2.
Summary
Beijing HuaCheng Taike Technology's Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) is filed under product code GEX, powered laser surgical instrument. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 878.4810. General, Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Beijing HuaCheng Taike Technology filed from Beijing, China. The decision came 88 calendar days after FDA received it (December 1, 2025 to February 27, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Beijing HuaCheng Taike Technology Co., Ltd.
- Product code
- Product code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Recent devices under product code GEX
view allMore clearances from Beijing HuaCheng Taike Technology Co., Ltd.
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.