Surgilase Yag 100 for Gynecology Use
FDA 510(k) K881499 · Surgilase, Inc.
510(k) numberK881499
Submission
- Device name
- Surgilase Yag 100 for Gynecology Use
- Applicant
- Surgilase, Inc.
Warwick, RI, US - Received
- March 22, 1988
- Decision date
- April 29, 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 |
| 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 |
| 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 |
|---|---|---|
| K932421 | Surgilase/Op 15, 20, 25, 30, 40, 50 CO2 Surg. LaseGEX · Traditional | 10/15/1993SE |
| K924664 | Surgilase Fiberlase CO2 Laser WaveguideGEX · Traditional | 04/15/1993SE |
| K905006 | Surgilase SL 150 Surgical Laser SystemGEX · Traditional | 02/21/1991SE |
| K904203 | Surgilase SL 50/60 Gold Surgical Laser SystemGEX · Traditional | 12/07/1990SE |
| K902211 | Surgilase Yag 100 Surgical Laser SystemGEX · Traditional | 06/29/1990SE |
| K900570 | Surgilase Yag 100 in Orthopedic SurgeryGEX · Traditional | 05/01/1990SE |
| K901227 | Surgilase CO2 Surgical Laser Systems Model SL120GEX · Traditional | 04/26/1990SE |
| K901211 | Surgilase SL50 Surgical Laser SystemGEX · Traditional | 04/26/1990SE |
| K894471 | Surgiprobes and Surgiscalpes in Head/Neck SurgeryGEX · Traditional | 11/14/1989SE |
| K894396 | Surgilase 25, 40, 45, 55, 60, 80, 100 LaserGEX · Traditional | 08/07/1989SE |
Questions and answers
When was Surgilase Yag 100 for Gynecology Use cleared by the FDA?
Surgilase Yag 100 for Gynecology Use (K881499) received a 510(k) decision of Substantially Equivalent on April 29, 1988, 38 days after the submission was received.
What is the product code of K881499?
The FDA product code is LLO – Laser, Neodymium:Yag, Pulmonary Surgery, a Class II (moderate risk) device regulated under 21 CFR 874.4500.