Data / Medical devices / China / Zhuzhou Goldenhot Medical Technology Co.,Ltd
Zhuzhou Goldenhot Medical Technology Co.,Ltd: FDA-registered device maker in Zhuzhou Hunan, China, 3 510(k) clearances
Zhuzhou Goldenhot Medical Technology Co.,Ltd is registered with the FDA (registration 3027847716) in Zhuzhou Hunan, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027847716
- Address
- Room 301, Plant C-3, Phase 5, Xinma Power Innovation Park, No. 889, Xianyue huan Road, Majiahe Street Tianyua District, Zhuzhou City, Hunan Province, China, Zhuzhou Hunan, China, 412007
- Owner or operator
- Zhuzhou Goldenhot Medical Technology Co.,Ltd. (10088566)
- Roles
- Manufacturer
- First device listed
- August 17, 2023
- Registered through
- 2026
- Brand names listed
- IIntense pulsed light device, models: DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, IPL Hair Removal Device, Model(s): DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G, Intense pulsed light device, models: DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G, Medical electronic thermometer (FC01, FC02)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Light Based Over-The-Counter Hair Removal | OHT | 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 |
|---|---|---|---|---|---|---|
| December 21, 2024 | K243085 | IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) | OHT | Substantially Equivalent | Zhuzhou Goldenhot Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 12, 2024 | K240109 | Medical electronic thermometer (FC01, FC02) | FLL | Substantially Equivalent | Zhuzhou Goldenhot Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 31, 2023 | K231613 | Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. | OHT | Substantially Equivalent | Zhuzhou Goldenhot Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Light Based Over-The-Counter Hair Removal
Updated December 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.