Data / Medical devices / South Korea / Y&j Bio Co., Ltd.
Y&j Bio Co., Ltd.: FDA-registered device maker in Hanam-si Gyeonggi, South Korea, 3 510(k) clearances
Y&j Bio Co., Ltd. is registered with the FDA (registration 3015415349) in Hanam-si Gyeonggi, South Korea. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 17, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015415349
- Address
- B-916, 947, Hanam-Daero, Hanam-si Gyeonggi, South Korea, 12982
- Owner or operator
- Y&J BIO Co., Ltd. (10060277)
- Roles
- Manufacturer
- First device listed
- April 18, 2019
- Registered through
- 2026
- Brand names listed
- Easy Hairfull, HAIRGROW, Hair Up, HairGrow Pro, MiiN-iHair, easy Claire
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Comb, Hair | OAP | 2 | Manufacturer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 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 |
|---|---|---|---|---|---|---|
| November 17, 2022 | K223278 | easy Claire | OHS | Substantially Equivalent | Y & J Bio Co., Ltd. | accessdata.fda.gov |
| December 8, 2020 | K202983 | easy Hairfull | OAP | Substantially Equivalent | Y & J Bio Co., Ltd. | accessdata.fda.gov |
| June 1, 2018 | K180617 | Hair Up | OAP | Substantially Equivalent | Y & J Bio Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 17, 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.