Model 4900 Nd:Yag Laser for Pulmonary Obstructions
FDA 510(k) K880170 · Cooper Lasersonics, Inc.
510(k) numberK880170
Submission
- Device name
- Model 4900 Nd:Yag Laser for Pulmonary Obstructions
- Applicant
- Cooper Lasersonics, Inc.
Santa Clara, CA, US - Received
- January 15, 1988
- Decision date
- March 24, 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 |
| 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 |
|---|---|---|
| K880809 | Illumina Model 55 CO2 Laser for General/Plastic SuGEX · Traditional | 04/18/1988SE |
| K880808 | Illumina Model 40 CO2 Laser for General/Plastic SuGEX · Traditional | 04/18/1988SE |
| K880807 | Illumina Model 25 CO2 Laser for General/Plastic SuGEX · Traditional | 04/18/1988SE |
| K880429 | Illumina 55 CO2 Laser SystemEWG · Traditional | 04/18/1988SE |
| K880428 | Illumina 25 CO2 Laser SystemEWG · Traditional | 04/18/1988SE |
| K880427 | Illumina 40 CO2 Laser SystemEWG · Traditional | 04/18/1988SE |
| K880171 | Model 4900 Nd:Yag Laser for Gastro & Genitour ApplLNK · Traditional | 04/11/1988SE |
| K880173 | Model 4900 Nd:Yag Laser for Endometrial AblationHHR · Traditional | 03/24/1988SE |
| K880172 | Model 4900 Nd:Yag Laser for Neurosurgery Applica.LKW · Traditional | 03/11/1988SE |
| K875115 | Infraguide(Tm)GEX · Traditional | 02/26/1988SE |
Questions and answers
When was Model 4900 Nd:Yag Laser for Pulmonary Obstructions cleared by the FDA?
Model 4900 Nd:Yag Laser for Pulmonary Obstructions (K880170) received a 510(k) decision of Substantially Equivalent on March 24, 1988, 69 days after the submission was received.
What is the product code of K880170?
The FDA product code is LLO – Laser, Neodymium:Yag, Pulmonary Surgery, a Class II (moderate risk) device regulated under 21 CFR 874.4500.