Heracure LS 500
FDA 510(k) K875078 · W.C. Heraeus GmbH
510(k) numberK875078
Submission
- Device name
- Heracure LS 500
- Applicant
- W.C. Heraeus GmbH
West Germany, DE - Received
- December 29, 1987
- Decision date
- February 22, 1988
- 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 |
| K872709 | Model 20-C, RL-20A/U, OB-10A/UHHR · Traditional | Directed Energy, Inc. | 02/02/1988SE |
More from Directed Energy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K895715 | Hanaulux(R) 2000FTD · Traditional | 10/13/1989SE |
Questions and answers
When was Heracure LS 500 cleared by the FDA?
Heracure LS 500 (K875078) received a 510(k) decision of Substantially Equivalent on February 22, 1988, 55 days after the submission was received.
What is the product code of K875078?
The FDA product code is HHR – Laser, Surgical, Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4550.