ND: Yaglaser for Palliative Treat of Obstruction
FDA 510(k) K852507 · Endo Lase, Inc.
510(k) numberK852507
Submission
- Device name
- ND: Yaglaser for Palliative Treat of Obstruction
- Applicant
- Endo Lase, Inc.
Washington, DC, US - Received
- June 12, 1985
- Decision date
- July 5, 1985
- 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.
| 510(k) | Device | Decision |
|---|---|---|
| K853900 | Endo-Lase CD40 for NeurosurgeryGEX · Traditional | 06/18/1986SE |
| K853878 | Endo-Lase CD-100 CO2 Laser for NeurosurgeryGEX · Traditional | 05/02/1986SE |
| K855093 | Medilas 2 Nd:Yag Laser Surgery SystemHHR · Traditional | 02/21/1986SE |
| K853903 | Endo-Lase CD40 CO2 for GynecologyHHR · Traditional | 02/21/1986SE |
| K853876 | Endo-Lse CD-100 CO2 Laser for GynecologyHHR · Traditional | 02/21/1986SE |
| K853901 | Endo-Lase CD 40 for DermatologyGEX · Traditional | 02/19/1986SE |
| K853877 | Endo-Lase CD-100 CO2 Laser for DermatologyGEX · Traditional | 02/19/1986SE |
| K853580 | Medilas 2LKW · Traditional | 02/13/1986SE |
| K860152 | Model 700 Evacuator for Use with Laser SurgeryLNK · Traditional | 02/05/1986SE |
| K853902 | Endo-Lase CD40 for OtorhinolaryngologyEWG · Traditional | 01/09/1986SE |
Questions and answers
When was ND: Yaglaser for Palliative Treat of Obstruction cleared by the FDA?
ND: Yaglaser for Palliative Treat of Obstruction (K852507) received a 510(k) decision of Substantially Equivalent on July 5, 1985, 23 days after the submission was received.
What is the product code of K852507?
The FDA product code is LLO – Laser, Neodymium:Yag, Pulmonary Surgery, a Class II (moderate risk) device regulated under 21 CFR 874.4500.