Fiberlase II Nd:Yag Laser for Pulmonary Use
FDA 510(k) K872351 · Laser Media
510(k) numberK872351
Submission
- Device name
- Fiberlase II Nd:Yag Laser for Pulmonary Use
- Applicant
- Laser Media
Hauppauge, NY, US - Received
- June 17, 1987
- Decision date
- December 11, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LLO – Laser, Neodymium:Yag, Pulmonary Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4500
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LLO
| 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 |
| 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 |
More from Cooper Lasersonics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K872352 | Fiberlase II Nd:Yag Laser for Treat of MenorrhagiaHHR · Traditional | 12/30/1987SE |
| K872350 | Fiberlase II Nd:Yag Laser for Gastro.&Urology UseLNK · Traditional | 08/10/1987SE |
| K872031 | Uni-Fiber Non-Repairable Fiber Delivery SystemLNK · Traditional | 08/04/1987SE |
| K863428 | Single Use Laser Fiber Delivery System for ND: YagLNK · Traditional | 12/03/1986SE |
| K863583 | Change in Fiberlase 100 Nd:Yag Medical LaserLNK · Traditional | 11/24/1986SE |
| K862444 | Fiberlase 100 Medical Laser Sys/Nd:Yag MenorrhagiaHHR · Traditional | 09/25/1986SE |
| K860063 | Nd:Yag Laser Single Use Fiber Delivery SystemLNK · Traditional | 02/05/1986SE |
| K855197 | Fiberlase 100 ND: Yag Medical Laser SystemLNK · Traditional | 01/21/1986SE |
| K852798 | Fiberlase 100 Medical Laser SystemLNK · Traditional | 07/29/1985SE |
| K850509 | Nd:Yag Fiberlase 100 Medical Laser SystemLNK · Traditional | 04/08/1985SE |
Questions and answers
When was Fiberlase II Nd:Yag Laser for Pulmonary Use cleared by the FDA?
Fiberlase II Nd:Yag Laser for Pulmonary Use (K872351) received a 510(k) decision of Substantially Equivalent on December 11, 1987, 177 days after the submission was received.
What is the product code of K872351?
The FDA product code is LLO – Laser, Neodymium:Yag, Pulmonary Surgery, a Class II (moderate risk) device regulated under 21 CFR 874.4500.