FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Intense Pulsed Light Therapy Device (MMABM-1)
K Number: K251545
·
Decision Sep 4, 2025
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
73
Applicant Total
1
Review Days
107
Basic Information
- Device Name
- Intense Pulsed Light Therapy Device (MMABM-1)
- K Number
- K251545
- 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
- Micowey Medical Equipment (Guangxi) Co., Ltd.
- Date Received
- May 20, 2025
- Decision Date
- September 4, 2025
- 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
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
MULA (K2-A1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery