Co 2 Surgical Laser System NA-120
FDA 510(k) K850818 · Xanar, Inc.
510(k) numberK850818
Submission
- Device name
- Co 2 Surgical Laser System NA-120
- Applicant
- Xanar, Inc.
Colorado Springs, CO, US - Received
- February 28, 1985
- Decision date
- August 15, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEX – Powered Laser Surgical Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology…
Other 510(k)s with product code GEX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)GEX · Traditional | Wuhan Pioon Technology Co., Ltd. | 09/10/2026SE |
| K261562 | Diode Laser Therapy SystemGEX · Traditional | Sanhe LEFIS Electronics Co., Ltd. | 09/10/2026SE |
| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 09/02/2026SE |
| K262269 | CO2 Laser System (MBT- CO2 Laser)GEX · Traditional | Beijing Mega Beauty Technology Co., Ltd. | 09/01/2026SE |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 08/27/2026SE |
| K262070 | Diode Laser Therapy Systems (DL612A)GEX · Traditional | Hebei Zollvan Medical Technology Co., Ltd. | 08/19/2026SE |
| K261964 | Echolaser X4GEX · Traditional | Elesta S.P.A | 08/19/2026SE |
| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 08/11/2026SE |
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Traditional | Olympus Surgical Technologies America | 07/24/2026SE |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q)GEX · Traditional | Rhein Laser Technologies Co., Ltd. | 07/21/2026SE |
More from Rhein Laser Technologies Co., Ltd.
| 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 |
| 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 |
| K837224 | Unknown · Traditional | 05/02/1983SE |
Questions and answers
When was Co 2 Surgical Laser System NA-120 cleared by the FDA?
Co 2 Surgical Laser System NA-120 (K850818) received a 510(k) decision of Substantially Equivalent on August 15, 1985, 168 days after the submission was received.
What is the product code of K850818?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.