Data / Medical devices / Taiwan / Gooten Innolife Corporation
Gooten Innolife Corporation: FDA-registered device maker in Taichung City, Taiwan, 1 510(k) clearance
Gooten Innolife Corporation is registered with the FDA (registration 3006368133) in Taichung City, Taiwan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 23, 2009. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006368133
- Address
- No. 12-1, Lane 267, Sec.3, Min Sheng Rd. Taya Dist., Taichung City, Taiwan, 42844
- Owner or operator
- Gooten Innolife Corporation (10024775)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- February 14, 2012
- Registered through
- 2026
- Brand names listed
- Lexington International LLC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Comb, Hair | OAP | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Contract manufacturer, Exporter to the US | 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 23, 2009 | K093499 | HAIRMAX LASERCOMB | OAP | Substantially Equivalent | Lexington International, LLC | accessdata.fda.gov |
Compare with other makers
Updated November 23, 2009. 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.