mmRNA appliance— 510(k) K210203
Substantially EquivalentVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)
FDA 510(k) clearance K210203 for mmRNA appliance, Substantially Equivalent on 2021-08-19. Applicant: Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I). Device class: 2.
Clearance details
- Applicant
- Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)
- Product code
- Code LRK
- Device class
- Class 2
- Regulation
- 21 CFR 872.5570
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Highland Ranch, CO, US
Recent devices under product code LRK
view allAdverse events under product code LRK
product code LRK- Injury
- 246
- Malfunction
- 1,044
- Total
- 1,290
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.