Data / Medical devices / United States / REVIAN, Inc
REVIAN, Inc: FDA-registered device maker in Morrisville, NC, United States, 2 510(k) clearances
REVIAN, Inc is registered with the FDA (registration 3015249767) in Morrisville, NC, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 13, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015249767
- Address
- 615 Davis Dr Ste 800, Morrisville, NC, United States, 27560
- Owner or operator
- REVIAN, Inc. (10059863)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 21, 2019
- Registered through
- 2026
- Brand names listed
- GetHairMD Hair Growth System (10013), LOCKrx Red Light Cap (10015), REVIAN Headliner Replacement Kit - Universal (12600), Replacement Kit, 120V AC-5VDC 2A Wall, Type A Plug (12707), Replacement Kit, REVIAN 2M USB Magnetic Cable V2 Only (12720), Replacement Kit, REVIAN 2M USB Magnetic Cable and Insert V2 (12722), Revian Lyte (10011), Revian Red (10001) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Comb, Hair | OAP | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 13, 2024 | K242441 | Revian Lyte (10011) | OAP | Substantially Equivalent | Revian, Inc. | accessdata.fda.gov |
| February 28, 2018 | K173729 | REVIAN RED | OAP | Substantially Equivalent | Photonmd, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 13, 2024. 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.