FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NuFACE Trinity
K Number: K181008
·
Decision Oct 11, 2018
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
77
Applicant Total
7
Review Days
177
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Basic Information
- Device Name
- NuFACE Trinity
- K Number
- K181008
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carol Cole Company Dba Nuface
- Date Received
- April 17, 2018
- Decision Date
- October 11, 2018
- Product Code
- NFO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | FDA class 2 | Neurology |
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Other Clearances by Carol Cole Company Dba Nuface
| K Number | Device Name | ||
|---|---|---|---|
| K212947 | Trinity Plus Wrinkle Reducer | Apr 2, 2022 | Substantially Equivalent |
| K201906 | Trinity ELE Plus and Trinity ELE Plus Pro | Feb 24, 2021 | Substantially Equivalent |
| K201782 | NuFace Trinity Plus Device | Jan 22, 2021 | Substantially Equivalent |
| K191672 | NuFACE Mini Device | Oct 15, 2019 | Substantially Equivalent |
| K182424 | NuFACE FIX Skin Toning Device | Dec 18, 2018 | Substantially Equivalent |
| K171588 | NuBODY Skin Toning Device | Jul 31, 2017 | Substantially Equivalent |