Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)— 510(k) K261701
Substantially EquivalentMicro-Energy Medical Technology Co., Ltd.
FDA 510(k) clearance K261701 for Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8), Substantially Equivalent on 2026-06-18. Applicant: Micro-Energy Medical Technology Co., Ltd.. Device class: 2.
Summary
Micro-Energy Medical Technology's Hemolase Fiber is listed in four models: Hemo-R-0.40-2.5, Hemo-R-0.60-2.5, Hemo-R-0.40-1.8, and Hemo-R-0.60-1.8. It's filed under GEX, powered laser surgical instruments, and the record doesn't explain the model numbering.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. It came in as a Special 510(k).
Micro-Energy filed from Shenzhen, China. Review took 27 calendar days (May 22 to June 18, 2026).
Clearance details
- Applicant
- Micro-Energy Medical 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
- Special
- Location
- Shenzhen, CN
Recent devices under product code GEX
view allMore clearances from Micro-Energy Medical 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.