S.L.T. Contact Laser Nd:Yag Use in Pulmonary Airwa
FDA 510(k) K855095 · Surgical Laser Technologies, Inc.
510(k) numberK855095
Submission
- Device name
- S.L.T. Contact Laser Nd:Yag Use in Pulmonary Airwa
- Applicant
- Surgical Laser Technologies, Inc.
Cincinnati, OH, US - Received
- December 23, 1985
- Decision date
- February 18, 1986
- 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 |
| K871511 | SL-100 Nd:Yag Laser for Pulmonary ObstructionsLLO · Traditional | Medical Energy, Inc. | 07/21/1987SE |
More from Medical Energy, Inc.
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|---|---|---|
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| K023624 | SLT Venous Fiber Delivery Systems, Model: 0041-6772/0041-6781/0041-6752/0041-6761/0041-69…GEX · Traditional | 01/27/2003SE |
| K011409 | SLT Laserpro CTH Holmium Laser SystemGEX · Traditional | 06/14/2001SE |
| K010041 | SLT Diffuser FiberGEX · Traditional | 03/07/2001SE |
| K984018 | Hemosleeve, Model 4.0MM, 5.5MMGEI · Traditional | 03/15/1999SE |
| K983050 | Pneumatic Cutter SystemERL · Traditional | 11/25/1998SE |
| K981041 | SLT Bipolar SheathERL · Traditional | 08/27/1998SE |
| K972548 | SLT CL MD Contact Laser SystemGEX · Traditional | 04/21/1998SE |
| K980156 | SLT Select Fiber Delivery System and Contact TipsGEX · Traditional | 02/27/1998SE |
| K960821 | SLT Fumich Probe GuideGEX · Traditional | 05/16/1996SE |
Questions and answers
When was S.L.T. Contact Laser Nd:Yag Use in Pulmonary Airwa cleared by the FDA?
S.L.T. Contact Laser Nd:Yag Use in Pulmonary Airwa (K855095) received a 510(k) decision of Substantially Equivalent on February 18, 1986, 57 days after the submission was received.
What is the product code of K855095?
The FDA product code is LLO – Laser, Neodymium:Yag, Pulmonary Surgery, a Class II (moderate risk) device regulated under 21 CFR 874.4500.