NuFace Trinity Plus Device
FDA 510(k) clearance K201782 · decided 2021-01-22
Clearance details
- K-number
- K201782
- Device name
- NuFace Trinity Plus Device
- Applicant
- Carol Cole Company Dba Nuface
- Decision
- Substantially Equivalent
- Date received
- 2020-06-30
- Decision date
- 2021-01-22
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- NFO
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Vista, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.