Contact Nd:Yag Laser for Treatment of Menorrhagia
FDA 510(k) K872253 · Surgical Laser Technologies, Inc.
510(k) numberK872253
Submission
- Device name
- Contact Nd:Yag Laser for Treatment of Menorrhagia
- Applicant
- Surgical Laser Technologies, Inc.
Malvern, PA, US - Received
- May 20, 1987
- Decision date
- October 6, 1987
- 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 |
|---|---|---|
| K042211 | Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsGEX · Traditional | 11/08/2004SE |
| K023624 | SLT Venous Fiber Delivery Systems, Model: 0041-6772/0041-6781/0041-6752/0041-6761/0041-69…GEX · Traditional | 01/27/2003SE |
| K011409 | SLT Laserpro CTH Holmium Laser SystemGEX · Traditional | 06/14/2001SE |
| K010041 | SLT Diffuser FiberGEX · Traditional | 03/07/2001SE |
| K984018 | Hemosleeve, Model 4.0MM, 5.5MMGEI · Traditional | 03/15/1999SE |
| K983050 | Pneumatic Cutter SystemERL · Traditional | 11/25/1998SE |
| K981041 | SLT Bipolar SheathERL · Traditional | 08/27/1998SE |
| K972548 | SLT CL MD Contact Laser SystemGEX · Traditional | 04/21/1998SE |
| K980156 | SLT Select Fiber Delivery System and Contact TipsGEX · Traditional | 02/27/1998SE |
| K960821 | SLT Fumich Probe GuideGEX · Traditional | 05/16/1996SE |
Questions and answers
When was Contact Nd:Yag Laser for Treatment of Menorrhagia cleared by the FDA?
Contact Nd:Yag Laser for Treatment of Menorrhagia (K872253) received a 510(k) decision of Substantially Equivalent on October 6, 1987, 139 days after the submission was received.
What is the product code of K872253?
The FDA product code is HHR – Laser, Surgical, Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4550.