Laser, Neurosurgical
Laser, Neurosurgical is a laser system specifically designed for use in neurosurgical procedures, used to cut, ablate, coagulate, or vaporize brain or spinal cord tissue with precision, typically in the treatment of tumors, arteriovenous malformations, or other neurosurgical conditions. This is an FDA Class 3 device, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The product code is LKW; no regulation number has been assigned. The review panel is Neurology.
Research product code LKW in seconds
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Basic Information
- Product Code
- LKW
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- NE
- Submission Type
- 3
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K875042 | ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY | Jun 24, 1988 | Substantially Equivalent | Surgilase, Inc. |
| K880172 | MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. | Mar 11, 1988 | Substantially Equivalent | Cooper Lasersonics, Inc. |
| K864166 | 25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY | Feb 10, 1987 | Substantially Equivalent | Weck Surgical Systems |
| K853580 | MEDILAS 2 | Feb 13, 1986 | Substantially Equivalent | Endo Lase, Inc. |
| K844440 | MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL | May 09, 1985 | Substantially Equivalent | Cooper Lasersonics, Inc. |