CO2 Surgical Laser System XML-10
FDA 510(k) K841860 · Xanar, Inc.
510(k) numberK841860
Submission
- Device name
- CO2 Surgical Laser System XML-10
- Applicant
- Xanar, Inc.
Colorado Springs, CO, US - Received
- May 4, 1984
- Decision date
- November 8, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EWG – Laser, Ent Microsurgical Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4500
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EWG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924652 | Benson CCA100EWG · Traditional | Benson Medical Instruments Co. | 04/09/1993SE |
| K870587 | Lasermatic Surgilaser Model 5050EWG · Traditional | Lasermatic OY | 08/10/1988SN |
| K880429 | Illumina 55 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K880428 | Illumina 25 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K880427 | Illumina 40 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K872710 | Model 20-B W/OB-10A/U Attach. for Ear, Nose/ThroatEWG · Traditional | Directed Energy, Inc. | 09/24/1987SE |
| K870840 | Model 20-C W/BR-20A/U Attach/Model HL-3.O AttachEWG · Traditional | Directed Energy, Inc. | 06/12/1987SE |
| K864975 | Laserscope Omniplus Photosurgical System for (ENT)EWG · Traditional | Laserscope | 02/25/1987SE |
| K862866 | Model 10-C W/LP-10A/U & OS-10A/U for Oral/Ent UseEWG · Traditional | Directed Energy, Inc. | 01/09/1987SE |
| K862865 | Model 10-C W/LP-10A/U & OB-10A/U for Oral/Ent UseEWG · Traditional | Directed Energy, Inc. | 01/09/1987SE |
More from Directed Energy, 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 |
| K833325 | Ambulase XAM-15 Xanar Surg. Laser · Traditional | 01/26/1984SE |
| K837224 | Unknown · Traditional | 05/02/1983SE |
Questions and answers
When was CO2 Surgical Laser System XML-10 cleared by the FDA?
CO2 Surgical Laser System XML-10 (K841860) received a 510(k) decision of Substantially Equivalent on November 8, 1984, 188 days after the submission was received.
What is the product code of K841860?
The FDA product code is EWG – Laser, Ent Microsurgical Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 874.4500.