Data / Medical devices / China / Guangzhou Enzoeys photoelectric Technology Co., Ltd.
Guangzhou Enzoeys photoelectric Technology Co., Ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 1 510(k) clearance
Guangzhou Enzoeys photoelectric Technology Co., Ltd. is registered with the FDA (registration 3033891767) in Guangzhou Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033891767
- Address
- 11/F, Building 1, Haihua Science & Technology Innovation Park, No. 62, Jinghu Avenue, Huadu District, Guangzhou Guangdong, China, 510800
- Owner or operator
- Guangzhou Enzoeys photoelectric Technology Co,Ltd. (10091858)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 8, 2024
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 21, 2024 | K240314 | MULA (K2-A1) | ONF | Substantially Equivalent | Guangzhou Ciellulu Photoelectric Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Powered Laser Surgical Instrument
Updated August 21, 2024. 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.