Laseguide 600A, 600B, 400A, 400B for Ob-Gyn Use
FDA 510(k) K880591 · Laser Peripherals, LLC
510(k) numberK880591
Submission
- Device name
- Laseguide 600A, 600B, 400A, 400B for Ob-Gyn Use
- Applicant
- Laser Peripherals, LLC
Hingham, MA, US - Received
- February 11, 1988
- Decision date
- June 1, 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 |
| 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 |
| 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 |
|---|---|---|
| K170366 | Laser Peripherals, LLC Family of Bare Laser FibersGEX · Traditional | 06/08/2017SE |
| K030959 | Bare Laser Fiber Models DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100GEX · Special | 04/25/2003SE |
| K011207 | Laser Peripherals Reusable Holmium FiberGEX · Traditional | 07/24/2001SE |
| K992083 | Scatterfree Lateral Emitting FiberGEX · Special | 07/12/1999SE |
| K974229 | LS-905 Fiberchoice Adapter SystemGEX · Traditional | 02/10/1998SE |
| K972272 | Laser Peripherals Holmium Bare FibersGEX · Traditional | 07/29/1997SE |
| K961516 | Laser Peripherals Inc. Bare FiberGEX · Traditional | 06/27/1996SE |
| K961079 | Laser Peripherals Inc. Scatterfree FiberGEX · Traditional | 05/22/1996SE |
| K901786 | Laseguide Cat # CLF-600D & CLF-1000DGEX · Traditional | 06/27/1990SE |
| K880592 | Laseguide 600A, 600B, 400A, 400B for Pulmonary UseLLO · Traditional | 04/25/1988SE |
Questions and answers
When was Laseguide 600A, 600B, 400A, 400B for Ob-Gyn Use cleared by the FDA?
Laseguide 600A, 600B, 400A, 400B for Ob-Gyn Use (K880591) received a 510(k) decision of Substantially Equivalent on June 1, 1988, 111 days after the submission was received.
What is the product code of K880591?
The FDA product code is HHR – Laser, Surgical, Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4550.