Medilas 2
FDA 510(k) K853580 · Endo Lase, Inc.
510(k) numberK853580
Submission
- Device name
- Medilas 2
- Applicant
- Endo Lase, Inc.
Washington, DC, US - Received
- August 26, 1985
- Decision date
- February 13, 1986
- 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 |
| K864166 | 25 Watt Carbon Dioxide Medical Laser for NeurologyLKW · Traditional | Weck Surgical Systems | 02/10/1987SE |
| K844440 | Model 4000 Nd:Yag Laser for Hemorrhage ControlLKW · Traditional | Cooper Lasersonics, Inc. | 05/09/1985SE |
More from Cooper Lasersonics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K853900 | Endo-Lase CD40 for NeurosurgeryGEX · Traditional | 06/18/1986SE |
| K853878 | Endo-Lase CD-100 CO2 Laser for NeurosurgeryGEX · Traditional | 05/02/1986SE |
| K855093 | Medilas 2 Nd:Yag Laser Surgery SystemHHR · Traditional | 02/21/1986SE |
| K853903 | Endo-Lase CD40 CO2 for GynecologyHHR · Traditional | 02/21/1986SE |
| K853876 | Endo-Lse CD-100 CO2 Laser for GynecologyHHR · Traditional | 02/21/1986SE |
| K853901 | Endo-Lase CD 40 for DermatologyGEX · Traditional | 02/19/1986SE |
| K853877 | Endo-Lase CD-100 CO2 Laser for DermatologyGEX · Traditional | 02/19/1986SE |
| K860152 | Model 700 Evacuator for Use with Laser SurgeryLNK · Traditional | 02/05/1986SE |
| K853902 | Endo-Lase CD40 for OtorhinolaryngologyEWG · Traditional | 01/09/1986SE |
| K853875 | Endo-Lase CD-100 CO2 Laser for OtorhinolaryngologyEWG · Traditional | 01/09/1986SE |
Questions and answers
When was Medilas 2 cleared by the FDA?
Medilas 2 (K853580) received a 510(k) decision of Substantially Equivalent on February 13, 1986, 171 days after the submission was received.
What is the product code of K853580?
The FDA product code is LKW – Laser, Neurosurgical, a Class III (high risk) device.