FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EON
K Number: K211681
·
Decision Mar 30, 2022
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
18
Applicant Total
3
Review Days
302
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Basic Information
- Device Name
- EON
- K Number
- K211681
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dominion Aesthetic Technologies, Inc.
- Date Received
- June 1, 2021
- Decision Date
- March 30, 2022
- Product Code
- PKT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PKT | Laser For Disruption Of Adipocyte Cells For Aesthetic Use | FDA class 2 | General, Plastic Surgery |
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