510(k) K864166
K864166 is an FDA 510(k) premarket notification submitted by Weck Surgical Systems for the device "25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY". The FDA issued a decision of Substantially Equivalent on February 10, 1987. The device falls under product code LKW (Laser, Neurosurgical), a Class III device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1987
- Date Received
- October 23, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Neurosurgical
- Device Class
- Class III
- Regulation Number
- Review Panel
- NE
- Submission Type