Data / Medical devices / Canada / Luvo Medical Technologies, Inc.
Luvo Medical Technologies, Inc.: FDA-registered device maker in Cambridge Ontario, Canada, 3 510(k) clearances
Luvo Medical Technologies, Inc. is registered with the FDA (registration 3016076698) in Cambridge Ontario, Canada. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 14, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016076698
- Address
- 125 Fleming Drive, Cambridge Ontario, Canada, N1T 2B8
- Owner or operator
- LUVO Medical Technologies, Inc. (10061631)
- Roles
- Manufacturer
- First device listed
- November 6, 2019
- Registered through
- 2026
- Brand names listed
- Bare: 808, Bela MD Synergist, Bela MD+, BelaMD+, Darwin, Lucent: IPL, WorldPRP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | 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 |
|---|---|---|---|---|---|---|
| July 14, 2021 | K203728 | Darwin | GEX | Substantially Equivalent | Luvo Medical Technologies, Inc. | accessdata.fda.gov |
| March 10, 2020 | K193446 | Bare: 808 | GEX | Substantially Equivalent | Luvo Medical Technologies, Inc. | accessdata.fda.gov |
| March 5, 2020 | K193072 | Lucent : IPL | ONF | Substantially Equivalent | Luvo Medical Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Platelet And Plasma Separator For Bone Graft Handling
- All makers of Brush, Dermabrasion, Powered
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Updated July 14, 2021. 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.