FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
InMode Diolaze System
K Number: K180719
·
Decision Jun 14, 2018
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
10
Review Days
87
Basic Information
- Device Name
- InMode Diolaze System
- K Number
- K180719
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- InMode MD Ltd.
- Date Received
- March 19, 2018
- Decision Date
- June 14, 2018
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 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 |
| K191855 | EmFace Device | Oct 29, 2019 | Substantially Equivalent |
| K183450 | EmBody System | Jun 20, 2019 | 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 |
| K160329 | InMode System MiniFX Handpiece | Aug 19, 2016 | Substantially Equivalent |
| K153568 | InMode Plus System | Jul 12, 2016 | Substantially Equivalent |