TheraFace LED
FDA 510(k) clearance K212155 · decided 2021-12-21
Clearance details
- K-number
- K212155
- Device name
- TheraFace LED
- Applicant
- Theragun, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-07-12
- Decision date
- 2021-12-21
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- OHS
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.