FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY
K Number: K864166
·
Decision Feb 10, 1987
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
1
Review Days
110
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Basic Information
- Device Name
- 25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY
- K Number
- K864166
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Weck Surgical Systems
- Date Received
- October 23, 1986
- Decision Date
- February 10, 1987
- Product Code
- LKW
- Advisory Committee
- Unknown
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| LKW | Laser, Neurosurgical | FDA class 3 | Unknown |
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