Ambulase XAM-15 Xanar Surg. Laser
FDA 510(k) K833325 · Xanar, Inc.
510(k) numberK833325
Submission
- Device name
- Ambulase XAM-15 Xanar Surg. Laser
- Applicant
- Xanar, Inc.
Walker, MI, US - Received
- September 27, 1983
- Decision date
- January 26, 1984
- 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 |
| K837224 | Unknown · Traditional | 05/02/1983SE |
Questions and answers
When was Ambulase XAM-15 Xanar Surg. Laser cleared by the FDA?
Ambulase XAM-15 Xanar Surg. Laser (K833325) received a 510(k) decision of Substantially Equivalent on January 26, 1984, 121 days after the submission was received.