Laseguide 600A, 600B, 400A, 400B for Pulmonary Use
FDA 510(k) K880592 · Laser Peripherals, LLC
510(k) numberK880592
Submission
- Device name
- Laseguide 600A, 600B, 400A, 400B for Pulmonary Use
- Applicant
- Laser Peripherals, LLC
Hingham, MA, US - Received
- February 11, 1988
- Decision date
- April 25, 1988
- 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 |
| 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 |
More from Cooper Lasersonics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K170366 | Laser Peripherals, LLC Family of Bare Laser FibersGEX · Traditional | 06/08/2017SE |
| K030959 | Bare Laser Fiber Models DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100GEX · Special | 04/25/2003SE |
| K011207 | Laser Peripherals Reusable Holmium FiberGEX · Traditional | 07/24/2001SE |
| K992083 | Scatterfree Lateral Emitting FiberGEX · Special | 07/12/1999SE |
| K974229 | LS-905 Fiberchoice Adapter SystemGEX · Traditional | 02/10/1998SE |
| K972272 | Laser Peripherals Holmium Bare FibersGEX · Traditional | 07/29/1997SE |
| K961516 | Laser Peripherals Inc. Bare FiberGEX · Traditional | 06/27/1996SE |
| K961079 | Laser Peripherals Inc. Scatterfree FiberGEX · Traditional | 05/22/1996SE |
| K901786 | Laseguide Cat # CLF-600D & CLF-1000DGEX · Traditional | 06/27/1990SE |
| K880591 | Laseguide 600A, 600B, 400A, 400B for Ob-Gyn UseHHR · Traditional | 06/01/1988SE |
Questions and answers
When was Laseguide 600A, 600B, 400A, 400B for Pulmonary Use cleared by the FDA?
Laseguide 600A, 600B, 400A, 400B for Pulmonary Use (K880592) received a 510(k) decision of Substantially Equivalent on April 25, 1988, 74 days after the submission was received.
What is the product code of K880592?
The FDA product code is LLO – Laser, Neodymium:Yag, Pulmonary Surgery, a Class II (moderate risk) device regulated under 21 CFR 874.4500.