Data / Medical devices / United States / Passiflora inc.
Passiflora inc.: FDA-registered device maker in Miami Beach, FL, United States, 4 510(k) clearances
Passiflora inc. is registered with the FDA (registration 3020659203) in Miami Beach, FL, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020659203
- Address
- Passiflora Inc. 1000 5th Street Suite 200, Miami Beach, FL, United States, 33139
- Owner or operator
- Passiflora Inc (10061598)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- October 31, 2019
- Registered through
- 2026
- Brand names listed
- In2 Patch, Tripollar Device, Zutta LED Mask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation | QRC | 2 | Complaint file establishment | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | PAY | 2 | Repackager or relabeler | 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 1, 2023 | K223595 | vPATCH | QRC | Substantially Equivalent | Virility Medical , Ltd. | accessdata.fda.gov |
| July 14, 2021 | K202390 | Aduro Light Beauty Mask | OHS | Substantially Equivalent | Shenzhen Kaiyan Medical CO , Ltd. | accessdata.fda.gov |
| February 25, 2021 | K203665 | STOP U Model UXV Device | PAY | Substantially Equivalent | Pollogen, Ltd. | accessdata.fda.gov |
| June 19, 2019 | K182774 | STOP U (Packed Black USA), STOP U (Packed White USA) | PAY | Substantially Equivalent | Pollogen, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Updated May 1, 2023. 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.