Data / Medical devices / China / Slinph Technologies Co., Ltd
Slinph Technologies Co., Ltd: FDA-registered device maker in Changsha Hunan, China, 3 510(k) clearances
Slinph Technologies Co., Ltd is registered with the FDA (registration 3013553501) in Changsha Hunan, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated December 8, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013553501
- Address
- Room201 and 202, Building B54, Jinke Yida Science & Technology City, No. 77 South Section of Dongliu Road Changsha Economic and Technological Development Zone, Changsha Hunan, China, 410100
- Owner or operator
- Slinph Technologies Co., LTD (10054743)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- April 20, 2017
- Registered through
- 2026
- Brand names listed
- IHelmet Hair Growth System, iHelmet Hair Growth System, model: LTD 160Pro, iHelmet Hair Growth System, model: LTD 36Air, iHelmet Hair Growth System, model: LTD 88Lite, iHelmet Laser Comb (model: SC8 Dual, SC12, SC16Pro)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Comb, Hair | OAP | 2 | Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler | 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 8, 2020 | K202631 | iHelmet Laser Comb | OAP | Substantially Equivalent | Slinph Technologies Co., Ltd. | accessdata.fda.gov |
| December 26, 2019 | K190467 | iHelmet Hair Growth System | OAP | Substantially Equivalent | Slinph Technologies Co., Ltd. | accessdata.fda.gov |
| April 4, 2017 | K162782 | iHelmet Hair Growth System | OAP | Substantially Equivalent | Slinph Technologies Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 8, 2020. 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.