FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
EmFace Device
K Number: K191855
·
Decision Oct 29, 2019
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
77
Applicant Total
21
Review Days
111
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Basic Information
- Device Name
- EmFace Device
- K Number
- K191855
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inmode MD , Ltd.
- Date Received
- July 10, 2019
- Decision Date
- October 29, 2019
- Product Code
- PBX
- 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 |
|---|---|---|---|
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Inmode MD , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K210492 | InMode RF Pro System | Jul 12, 2021 | Substantially Equivalent |
| K192695 | InMode System with the Morpheus8 (Fractora) Applicators | Dec 27, 2019 | Substantially Equivalent |
| K183450 | EmBody System | Jun 20, 2019 | Substantially Equivalent |
| K182325 | InMode RF System | Sep 26, 2018 | Substantially Equivalent |
| K180719 | InMode Diolaze System | Jun 14, 2018 | Substantially Equivalent |
| K180189 | InMode System with Fractora3D/3D-90 Applicators | Jun 1, 2018 | Substantially Equivalent |
| K173677 | InMode VLaze | Feb 23, 2018 | Substantially Equivalent |
| K172302 | InMode PLUS System | Dec 8, 2017 | Substantially Equivalent |
| K171593 | InMode RF System | Oct 10, 2017 | Substantially Equivalent |
| K170738 | InMode Diolaze XL | Aug 7, 2017 | Substantially Equivalent |