Model XA-15 Laser System for Surgery
FDA 510(k) K837216 · Xanar, Inc.
510(k) numberK837216
Submission
- Device name
- Model XA-15 Laser System for Surgery
- Applicant
- Xanar, Inc.
Colorado Springs, CO, US - Received
- February 28, 1983
- Decision date
- April 4, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Xanar, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861688 | Xanar CO2 Surgical Laser System Model XAP-15GEX · Traditional | 10/03/1986SE |
| K852436 | AmbulaseGEX · Traditional | 04/18/1986SE |
| K860496 | Model NY-110 for Upper & Lower (Gu) & PulmonaryLNK · Traditional | 03/14/1986SE |
| K853620 | Model XA-50 - CO2 Surgical LaserGEX · Traditional | 01/24/1986SE |
| K850818 | Co 2 Surgical Laser System NA-120GEX · Traditional | 08/15/1985SE |
| K850805 | Co 2 Surgical Laser System Model NA-40GEX · Traditional | 08/15/1985SE |
| K850804 | Co 2 Surgical Laser System NA-30GEX · Traditional | 08/15/1985SE |
| K844087 | Xanar Model XSE-300 Smoke EvaculaterFYD · Traditional | 02/27/1985SE |
| K841860 | CO2 Surgical Laser System XML-10EWG · Traditional | 11/08/1984SE |
| K833325 | Ambulase XAM-15 Xanar Surg. Laser · Traditional | 01/26/1984SE |
Questions and answers
When was Model XA-15 Laser System for Surgery cleared by the FDA?
Model XA-15 Laser System for Surgery (K837216) received a 510(k) decision of Substantially Equivalent on April 4, 1983, 35 days after the submission was received.