Fiberlase 100 Medical Laser Sys/Nd:Yag Menorrhagia
FDA 510(k) K862444 · Laser Media
510(k) numberK862444
Submission
- Device name
- Fiberlase 100 Medical Laser Sys/Nd:Yag Menorrhagia
- Applicant
- Laser Media
Hauppauge, NY, US - Received
- June 26, 1986
- Decision date
- September 25, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHR – Laser, Surgical, Gynecologic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4550
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HHR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881507 | Endocoagulator Model 20 Laser & AccessoriesHHR · Traditional | Hgm Medical Laser Systems, Inc. | 04/27/1989SE |
| K871875 | Model 5050 Surgilaser for Ob-Gyn UseHHR · Traditional | Lasermatic, Inc. | 08/22/1988SE |
| K875314 | GL-35 Colposcopic Laser SystemHHR · Traditional | Laser Engineering, Inc. | 08/05/1988SE |
| K874615 | Laser Cannister FilterHHR · Traditional | Medical Marketing, Inc. | 06/23/1988SE |
| K880591 | Laseguide 600A, 600B, 400A, 400B for Ob-Gyn UseHHR · Traditional | Laser Peripherals, LLC | 06/01/1988SE |
| K880930 | MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LaseHHR · Traditional | Copper Lasersonics, Inc. | 05/31/1988SE |
| K880991 | Laser Optical Catheter SystemHHR · Traditional | Medline Industries, Inc. | 05/25/1988SE |
| K880173 | Model 4900 Nd:Yag Laser for Endometrial AblationHHR · Traditional | Cooper Lasersonics, Inc. | 03/24/1988SE |
| K874837 | KTP/532 Laser for Ob-Gyn UseHHR · Traditional | Laserscope | 03/14/1988SE |
| K875078 | Heracure LS 500HHR · Traditional | W.C. Heraeus GmbH | 02/22/1988SE |
More from W.C. Heraeus GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K872352 | Fiberlase II Nd:Yag Laser for Treat of MenorrhagiaHHR · Traditional | 12/30/1987SE |
| K872351 | Fiberlase II Nd:Yag Laser for Pulmonary UseLLO · Traditional | 12/11/1987SE |
| K872350 | Fiberlase II Nd:Yag Laser for Gastro.&Urology UseLNK · Traditional | 08/10/1987SE |
| K872031 | Uni-Fiber Non-Repairable Fiber Delivery SystemLNK · Traditional | 08/04/1987SE |
| K863428 | Single Use Laser Fiber Delivery System for ND: YagLNK · Traditional | 12/03/1986SE |
| K863583 | Change in Fiberlase 100 Nd:Yag Medical LaserLNK · Traditional | 11/24/1986SE |
| K860063 | Nd:Yag Laser Single Use Fiber Delivery SystemLNK · Traditional | 02/05/1986SE |
| K855197 | Fiberlase 100 ND: Yag Medical Laser SystemLNK · Traditional | 01/21/1986SE |
| K852798 | Fiberlase 100 Medical Laser SystemLNK · Traditional | 07/29/1985SE |
| K850509 | Nd:Yag Fiberlase 100 Medical Laser SystemLNK · Traditional | 04/08/1985SE |
Questions and answers
When was Fiberlase 100 Medical Laser Sys/Nd:Yag Menorrhagia cleared by the FDA?
Fiberlase 100 Medical Laser Sys/Nd:Yag Menorrhagia (K862444) received a 510(k) decision of Substantially Equivalent on September 25, 1986, 91 days after the submission was received.
What is the product code of K862444?
The FDA product code is HHR – Laser, Surgical, Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4550.