Data / Medical devices / Hong Kong / China 1 Link, Ltd
China 1 Link, Ltd: FDA-registered device maker in Mongkok Kowloon, Hong Kong, 4 510(k) clearances
China 1 Link, Ltd is registered with the FDA (registration 3012512142) in Mongkok Kowloon, Hong Kong. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 16, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012512142
- Address
- 101 Sai Yeung Choi Street South 3/F Rammon House, Mongkok Kowloon, Hong Kong, 523941
- Owner or operator
- China 1 Link, LTD (10055366)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- July 13, 2017
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 16, 2019 | K183329 | Laser Hair Therapy | OAP | Substantially Equivalent | Omm Imports, Inc. D/B/A Zero Gravity | accessdata.fda.gov |
| June 7, 2018 | K172909 | ELEVARE, PERFECTIO 4 | OHS | Substantially Equivalent | Omm Imports D/B/A Zero Gravity | accessdata.fda.gov |
| May 1, 2018 | K172555 | SAPPHIRE, ELEVARE SAPPHIRE | OLP | Substantially Equivalent | Omm Imports, Inc. D/B/A Zero Gravity | accessdata.fda.gov |
| February 25, 2016 | K152332 | Perfectio LED infrared device | OHS | Substantially Equivalent | Omm Imports Inc Dba Zero Gravity | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Massager, Therapeutic, Electric
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Laser, Comb, Hair
Updated January 16, 2019. 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.