FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
SMAXEL CO2 Surgical Laser System
K Number: K180036
·
Decision Feb 2, 2018
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
34
Applicant Total
4
Review Days
28
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Basic Information
- Device Name
- SMAXEL CO2 Surgical Laser System
- K Number
- K180036
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ids, Ltd.
- Date Received
- January 5, 2018
- Decision Date
- February 2, 2018
- 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 |
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