Data / Medical devices / United States / Cycle Clarity
Cycle Clarity: FDA-registered device maker in Awendaw, SC, United States, 1 510(k) clearance
Cycle Clarity is registered with the FDA (registration 3024972425) in Awendaw, SC, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 19, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024972425
- Address
- 1209 Fifteen Mile Landing Rd., Awendaw, SC, United States, 29429
- Owner or operator
- Cycle Clarity (10086465)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 11, 2022
- Registered through
- 2026
- Brand names listed
- Follicle Clarity
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| January 19, 2022 | K212012 | Follicle Clarity | QIH | Substantially Equivalent | Cycle Clarity | accessdata.fda.gov |
Compare with other makers
Updated January 19, 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.