Data / Medical devices / United States / Zerigo Health, Inc.
Zerigo Health, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 1 510(k) clearance
Zerigo Health, Inc. is registered with the FDA (registration 3013229265) in Carlsbad, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 23, 2017. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3013229265
- Address
- 6300 Yarrow Dr, Suite 102, Carlsbad, CA, United States, 92011
- Owner or operator
- Zerigo Health, Inc. (10055684)
- Roles
- Specification developer
- First device listed
- September 13, 2017
- Registered through
- 2027
- Brand names listed
- Clarify Medical, Inc.
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light, Ultraviolet, Dermatological | FTC | 2 | 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 |
|---|---|---|---|---|---|---|
| May 23, 2017 | K170489 | Skylit Phototherapy System | FTC | Substantially Equivalent | Skylit Medical | accessdata.fda.gov |
Compare with other makers
Updated May 23, 2017. 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.