Surgi-Light Disposable System for Pulmonology Use
FDA 510(k) K875104 · Laserguide
510(k) numberK875104
Submission
- Device name
- Surgi-Light Disposable System for Pulmonology Use
- Applicant
- Laserguide
Santa Barbara, CA, US - Received
- December 18, 1987
- Decision date
- February 2, 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 |
| 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 |
| 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 |
|---|---|---|
| K880071 | Surgi-Light Nd:Yag Laser for Urological UseFCS · Traditional | 03/22/1988SE |
| K873892 | Surgi-Light Dispos.Fiberoptic Del/Sys Gi/Uro UseLNK · Traditional | 02/02/1988SE |
| K873664 | Light-Spot Fiberoptic Laser HandpieceGEX · Traditional | 11/06/1987SE |
| K873571 | Light-Touch Fiberoptic Microcontact ProbeGEX · Traditional | 11/06/1987SE |
Questions and answers
When was Surgi-Light Disposable System for Pulmonology Use cleared by the FDA?
Surgi-Light Disposable System for Pulmonology Use (K875104) received a 510(k) decision of Substantially Equivalent on February 2, 1988, 46 days after the submission was received.
What is the product code of K875104?
The FDA product code is LLO – Laser, Neodymium:Yag, Pulmonary Surgery, a Class II (moderate risk) device regulated under 21 CFR 874.4500.