FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Multifrax Laser System
K Number: K213332
·
Decision Jun 3, 2022
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
34
Applicant Total
1
Review Days
240
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
- Multifrax Laser System
- K Number
- K213332
- 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
- Paradigm Medical Corporation
- Date Received
- October 6, 2021
- Decision Date
- June 3, 2022
- Product Code
- ONG
- 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 |
|---|---|---|---|
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ONG), ordered by most recent decision date.
AVAVA Skin Treatment System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
eCO2 3D
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Fiber Laser Treatment Systems (HS-232,HS-233)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AVAVA Skin Treatment System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MOSAIC 3D (Surgical Laser)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Miria Skin Treatment System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery