FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
SCIZER (SC1-M410)
K Number: K230100
·
Decision Nov 3, 2023
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
29
Applicant Total
3
Review Days
294
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
- SCIZER (SC1-M410)
- K Number
- K230100
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4590
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Classys, Inc.
- Date Received
- January 13, 2023
- Decision Date
- November 3, 2023
- Product Code
- OHV
- 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 |
|---|---|---|---|
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OHV), ordered by most recent decision date.
Ulthera® System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ulthera System (UC-1 Control Unit PRIME Model 2.1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ulthera® System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SofWave System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ulthera System (UC-1 Control Unit PRIME)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SofWave System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery