EON
FDA 510(k) clearance K211681 · decided 2022-03-30
Clearance details
- K-number
- K211681
- Device name
- EON
- Applicant
- Dominion Aesthetic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-01
- Decision date
- 2022-03-30
- Days to decision
- 302 days
- Clearance type
- Traditional
- Product code
- PKT
- Device class
- 2
- Regulation number
- 878.5400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Winter Park, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.