25 Watt Carbon Dioxide Medical Laser for Neurology
FDA 510(k) K864166 · Weck Surgical Systems
510(k) numberK864166
Submission
- Device name
- 25 Watt Carbon Dioxide Medical Laser for Neurology
- Applicant
- Weck Surgical Systems
Hauppauge, NY, US - Received
- October 23, 1986
- Decision date
- February 10, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LKW – Laser, Neurosurgical
- Device class
- Class III (high risk)
Other 510(k)s with product code LKW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K875042 | Nd:Yag 100 Surgical Laser for Neuro & PulmonaryLKW · Traditional | Surgilase, Inc. | 06/24/1988SE |
| K880172 | Model 4900 Nd:Yag Laser for Neurosurgery Applica.LKW · Traditional | Cooper Lasersonics, Inc. | 03/11/1988SE |
| K853580 | Medilas 2LKW · Traditional | Endo Lase, Inc. | 02/13/1986SE |
| K844440 | Model 4000 Nd:Yag Laser for Hemorrhage ControlLKW · Traditional | Cooper Lasersonics, Inc. | 05/09/1985SE |
Questions and answers
When was 25 Watt Carbon Dioxide Medical Laser for Neurology cleared by the FDA?
25 Watt Carbon Dioxide Medical Laser for Neurology (K864166) received a 510(k) decision of Substantially Equivalent on February 10, 1987, 110 days after the submission was received.
What is the product code of K864166?
The FDA product code is LKW – Laser, Neurosurgical, a Class III (high risk) device.