FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
E>EyeC
K Number: K200616
·
Decision Jun 11, 2020
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
73
Applicant Total
1
Review Days
94
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
- E>EyeC
- K Number
- K200616
- 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
- E-Swin
- Date Received
- March 9, 2020
- Decision Date
- June 11, 2020
- Product Code
- ONF
- 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 |
|---|---|---|---|
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ONF), ordered by most recent decision date.
Intense Pulsed Light Therapy Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Intense Pulsed Light Therapy Device (MMABM-1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDILIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IPL Treatment Device (MDSQMC-01)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEKA LOTUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Intense Pulsed Light Treatment System (LK-PT)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery