Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)— 510(k) K253829
Substantially EquivalentBeijing HuaCheng Taike Technology Co., Ltd.
FDA 510(k) clearance K253829 for Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532), Substantially Equivalent on 2026-02-27. Applicant: Beijing HuaCheng Taike Technology Co., Ltd.. Device class: 2.
Summary
Beijing HuaCheng Taike Technology filed the Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) under product code GEX, powered laser surgical instrument. The record gives no description beyond the name and that code name.
Class II, 21 CFR 878.4810. General, Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
The company filed from Beijing, China. FDA found it substantially equivalent 88 calendar days after receipt (December 1, 2025 to February 27, 2026).
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.