Model NY-110 for Upper & Lower (Gu) & Pulmonary
FDA 510(k) K860496 · Xanar, Inc.
510(k) numberK860496
Submission
- Device name
- Model NY-110 for Upper & Lower (Gu) & Pulmonary
- Applicant
- Xanar, Inc.
Colorado Springs, CO, US - Received
- February 10, 1986
- Decision date
- March 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LNK – Laser For Gastro-Urology Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LNK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K925395 | Technomed Pulsolith 4000 Laser SystemLNK · Traditional | Teknomed, Inc. | 05/21/1993SE |
| K901723 | MDL-2000 LasertripterLNK · Traditional | Candela Laser Corp. | 07/13/1990SE |
| K874255 | Nd:Yag Surgical Laser for Endo. Gastro/Uro. Appli.LNK · Traditional | Minnesota Laser Corp. | 07/12/1988SE |
| K874253 | Nd:Yag Surgical Laser for Gastro/Urology Applica.LNK · Traditional | Minnesota Laser Corp. | 07/12/1988SE |
| K880256 | Model 4060 N Nd:Yag Laser for Gastroenterology UseLNK · Traditional | Sharplan Lasers, Inc. | 04/14/1988SE |
| K880193 | Model 4060 N Nd:Yag Laser for Urological UseLNK · Traditional | Sharplan Lasers, Inc. | 04/14/1988SE |
| K875039 | Nd:Yag 100 Surgical Laser for Gastro. and UrologyLNK · Traditional | Surgilase, Inc. | 04/13/1988SE |
| K880171 | Model 4900 Nd:Yag Laser for Gastro & Genitour ApplLNK · Traditional | Cooper Lasersonics, Inc. | 04/11/1988SE |
| K871934 | Model 5050 Surgilaser for Gastro-Intestinal UseLNK · Traditional | Lasermatic, Inc. | 03/25/1988SE |
| K871932 | Model 5050 Surgilaser for Urology UseLNK · Traditional | Lasermatic, Inc. | 03/25/1988SE |
More from Lasermatic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861688 | Xanar CO2 Surgical Laser System Model XAP-15GEX · Traditional | 10/03/1986SE |
| K852436 | AmbulaseGEX · Traditional | 04/18/1986SE |
| 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 |
| K837224 | Unknown · Traditional | 05/02/1983SE |
Questions and answers
When was Model NY-110 for Upper & Lower (Gu) & Pulmonary cleared by the FDA?
Model NY-110 for Upper & Lower (Gu) & Pulmonary (K860496) received a 510(k) decision of Substantially Equivalent on March 14, 1986, 32 days after the submission was received.
What is the product code of K860496?
The FDA product code is LNK – Laser For Gastro-Urology Use, a Class II (moderate risk) device regulated under 21 CFR 878.4810.