Data / Medical devices / China / Micro-Energy Medical Technology Co., Ltd.
Micro-Energy Medical Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances
Micro-Energy Medical Technology Co., Ltd. is registered with the FDA (registration 3042261306) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 18, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3042261306
- Address
- Section B4301, B4701 and B4901, No. 13, Baolan Road, Kengzi Street, Pingshan District, Shenzhen Guangdong, China, 518118
- Owner or operator
- Micro-Energy Medical Technology Co., Ltd. (10094236)
- Roles
- Manufacturer
- First device listed
- November 19, 2025
- Registered through
- 2027
- Brand names listed
- Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R- 0.60-1.8/Novo-R-0.40-1.8), Hemo Luer Lock, Hemo Needle, 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), MEIM Therapeutic Shockwave Massager (model: KineShock 10 / KineShock 20), SurgiLight 1470 Diode Laser System (Model:Halo)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 18, 2026 | K261701 | 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) | GEX | Substantially Equivalent | Micro-Energy Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 12, 2025 | K252745 | Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) | GEX | Substantially Equivalent | Micro-Energy Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 2, 2025 | K251049 | SurgiLight 1470 Diode Laser System (Model:Halo) | GEX | Substantially Equivalent | Micro-Energy Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Guide, Needle, Surgical
- All makers of Powered Laser Surgical Instrument
- All makers of Massager, Therapeutic, Electric
- All makers of Accessories, Catheter
Updated June 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.