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Data / Medical devices / Canada / Inbella Medical Inc.

Inbella Medical Inc.: FDA-registered device maker in Richmond Hill Ontario, Canada, 5 510(k) clearances

Inbella Medical Inc. is registered with the FDA (registration 3036803067) in Richmond Hill Ontario, Canada. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated January 27, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3036803067
Address
100 Leek Crescent, unit 13, Richmond Hill Ontario, Canada, L4B3E6
Owner or operator
Inbella Medical Inc. (10092855)
Roles
Manufacturer
First device listed
March 5, 2025
Registered through
2026
Brand names listed
24-pin tip, 40-pin (Body) tip, Bella Body (NP172296D), Bella Face (NP101396D), Bella Turbo 10 (NP102206D), Bella Turbo 25 (NP253966D), Bella515 Black Aapplicator, Bella580 Black Aapplicator and more

Devices it lists

DeviceProduct codeClassRoleSource
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 27, 2026K251435InbellaIgnite RF SystemGEISubstantially EquivalentInbella Medical, Inc.accessdata.fda.gov
October 15, 2025K252367InbellaMulti SystemGEISubstantially EquivalentInbella Medical, Inc.accessdata.fda.gov
July 25, 2025K252215InbellaMAX SystemGEISubstantially EquivalentInbella Medical , Ltd.accessdata.fda.gov
February 11, 2025K250200InbellaBody SystemGEISubstantially EquivalentInbella Medical, Inc.accessdata.fda.gov
January 3, 2025K243737Inbella RF SystemGEISubstantially EquivalentInbella Medical, Inc.accessdata.fda.gov

Compare with other makers

Updated January 27, 2026. 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.