FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
InMode System with Fractora3D/3D-90 Applicators
K Number: K180189
·
Decision Jun 1, 2018
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
21
Review Days
129
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- InMode System with Fractora3D/3D-90 Applicators
- K Number
- K180189
- 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
- January 23, 2018
- Decision Date
- June 1, 2018
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoolSeal Generator® (CSL-200-90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROMARK System (NMK00301)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAP-iX2N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MILAN System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| K191855 | EmFace Device | Oct 29, 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 |
| 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 |