SL-100 Nd:Yag Laser for Pulmonary Obstructions
FDA 510(k) K871511 · Medical Energy, Inc.
510(k) numberK871511
Submission
- Device name
- SL-100 Nd:Yag Laser for Pulmonary Obstructions
- Applicant
- Medical Energy, Inc.
Pensacola, FL, US - Received
- April 20, 1987
- Decision date
- July 21, 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 |
| 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 |
| 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 |
|---|---|---|
| K041419 | Lightforce LF 20/30 980NM Surgical Diode Laser SystemGEX · Traditional | 08/26/2004SE |
| K871512 | SL-100 Nd:Yag Laser for Gynecology UseGEX · Traditional | 07/08/1988SE |
| K871516 | SL-100 Nd:Yag Laser for Urologic SurgeryLNK · Traditional | 07/09/1987SE |
| K871515 | SL-100 Nd:Yag Laser for Gastrointestinal BleedingLNK · Traditional | 07/09/1987SE |
| K871514 | SL-100 Nd:Yag Laser for Rectal Patho. & HemorrhoidLNK · Traditional | 07/09/1987SE |
| K871513 | SL-100 Nd:Yag Laser for Palliation of Gastro. MaliLNK · Traditional | 07/09/1987SE |
Questions and answers
When was SL-100 Nd:Yag Laser for Pulmonary Obstructions cleared by the FDA?
SL-100 Nd:Yag Laser for Pulmonary Obstructions (K871511) received a 510(k) decision of Substantially Equivalent on July 21, 1987, 92 days after the submission was received.
What is the product code of K871511?
The FDA product code is LLO – Laser, Neodymium:Yag, Pulmonary Surgery, a Class II (moderate risk) device regulated under 21 CFR 874.4500.