Data / Medical devices / China / Shenzhen Ishine Technology Company Limited
Shenzhen Ishine Technology Company Limited: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Ishine Technology Company Limited is registered with the FDA (registration 3021338880) in Shenzhen Guangdong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 14, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021338880
- Address
- Room 213 Building 4,No.45, Makan Road,Makan Community,Xili Sub-District,Nanshan District, Shenzhen Guangdong, China, 518055
- Owner or operator
- SHENZHEN ISHINE TECHNOLOGY COMPANY LIMITED (10086240)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 25, 2022
- Registered through
- 2026
- Brand names listed
- IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| October 14, 2022 | K222537 | IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi | OHT | Substantially Equivalent | Shenzhen Ishine Technology Company Limited | accessdata.fda.gov |
Compare with other makers
Updated October 14, 2022. 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.