Laser, Neodymium:Yag, Pulmonary Surgery
FDA product code LLO · Class II (moderate risk) · 21 CFR 874.4500 · Ear, Nose, Throat
19510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Cooper Lasersonics, Inc. 3
- Laser Media 2
- Surgical Laser Technologies, Inc. 2
- Endo Lase, Inc. 1
- Inframed, Inc. 1
- Sharplan Industries, Inc. 1
- Richard Wolf Medical Instruments Corp. 1
- Pilling Co. 1
- Medical Energy, Inc. 1
- Trimedyne, Inc. 1
- Lasermatic, Inc. 1
- Laserguide 1
- Minnesota Laser Corp. 1
- Laser Peripherals, LLC 1
- Surgilase, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884815 | SLT CLMD Contact LaserLLO · Traditional | Surgical Laser Technologies, Inc. | 12/22/1988SE |
| K881499 | Surgilase Yag 100 for Gynecology UseLLO · Traditional | Surgilase, Inc. | 04/29/1988SE |
| K880592 | Laseguide 600A, 600B, 400A, 400B for Pulmonary UseLLO · Traditional | Laser Peripherals, LLC | 04/25/1988SE |
| K880170 | Model 4900 Nd:Yag Laser for Pulmonary ObstructionsLLO · Traditional | Cooper Lasersonics, Inc. | 03/24/1988SE |
| K874254 | Nd:Yag Surgical Laser for Pulmonary ApplicationsLLO · Traditional | Minnesota Laser Corp. | 03/04/1988SE |
| K875104 | Surgi-Light Disposable System for Pulmonology UseLLO · Traditional | Laserguide | 02/02/1988SE |
| K871876 | Model 5050 Surgilaser for Pulmonary UseLLO · Traditional | Lasermatic, Inc. | 01/22/1988SE |
| K872351 | Fiberlase II Nd:Yag Laser for Pulmonary UseLLO · Traditional | Laser Media | 12/11/1987SE |
| K870505 | Optilase Yag Model 1000 Surg Laser Sys/Pulmon ApplLLO · Traditional | Trimedyne, Inc. | 08/07/1987SE |
| K871511 | SL-100 Nd:Yag Laser for Pulmonary ObstructionsLLO · Traditional | Medical Energy, Inc. | 07/21/1987SE |
| K862698 | 6000 Nd:Yag Laser for Benign/Malignant ObstructionLLO · Traditional | Cooper Lasersonics, Inc. | 08/05/1986SE |
| K861921 | Laser Bronchoscope SystemLLO · Traditional | Pilling Co. | 06/02/1986SE |
| K861583 | CO2 Laser Bronchoscope SystemLLO · Traditional | Richard Wolf Medical Instruments Corp. | 05/21/1986SE |
| K861045 | Model 2100 Nd:Yag Surgical Laser Pulmonary IndicatLLO · Traditional | Sharplan Industries, Inc. | 04/23/1986SE |
| K855095 | S.L.T. Contact Laser Nd:Yag Use in Pulmonary AirwaLLO · Traditional | Surgical Laser Technologies, Inc. | 02/18/1986SE |
| K852761 | Cilas Model YM101LLO · Traditional | Inframed, Inc. | 11/14/1985SE |
| K852507 | ND: Yaglaser for Palliative Treat of ObstructionLLO · Traditional | Endo Lase, Inc. | 07/05/1985SE |
| K850432 | Laser Benign & Malignant Pulmonary Obstructions-LLO · Traditional | Cooper Lasersonics, Inc. | 02/15/1985SE |
| K844869 | Fiberlase 100 Medical Laser SystemLLO · Traditional | Laser Media | 01/14/1985SE |