FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NeuroBlate System
K Number: K182036
·
Decision Oct 15, 2018
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
11
Review Days
77
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
- NeuroBlate System
- K Number
- K182036
- 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
- Monteris Medical,
- Date Received
- July 30, 2018
- Decision Date
- October 15, 2018
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PICOSURE WORKSTATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LumiGlam Laser System (SHE-LSP601-3)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LASEmaR 1500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUNE PureHygiene
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Boston 2910 (Boston 2910)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Monteris Medical,
| K Number | Device Name | ||
|---|---|---|---|
| K240877 | Monteris Medical NeuroBlate System | Jun 4, 2024 | Substantially Equivalent |
| K231061 | NeuroBlate System | Dec 8, 2023 | Substantially Equivalent |
| K222983 | NeuroBlate Fusion-S Software V3.17 | Mar 15, 2023 | Substantially Equivalent |
| K193375 | NeuroBlate System | Jan 3, 2020 | Substantially Equivalent |
| K173305 | NeuroBlate System | Nov 17, 2017 | Substantially Equivalent |
| K172881 | NeuroBlate System | Oct 20, 2017 | Substantially Equivalent |
| K170724 | NeuroBlate System | Apr 7, 2017 | Substantially Equivalent |
| K132444 | ATAMA SYSTEM | Jan 27, 2014 | Substantially Equivalent |
| K090240 | MONTERIS MEDICAL UFO | Aug 6, 2009 | Substantially Equivalent |
| K081509 | MONTERIS MEDICAL AUTOLITT LASER PROBE | May 1, 2009 | Substantially Equivalent |