MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 Lase
FDA 510(k) K880930 · Copper Lasersonics, Inc.
510(k) numberK880930
Submission
- Device name
- MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 Lase
- Applicant
- Copper Lasersonics, Inc.
Santa Clara, CA, US - Received
- March 4, 1988
- Decision date
- May 31, 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 |
| 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 |
Questions and answers
When was MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 Lase cleared by the FDA?
MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 Lase (K880930) received a 510(k) decision of Substantially Equivalent on May 31, 1988, 88 days after the submission was received.
What is the product code of K880930?
The FDA product code is HHR – Laser, Surgical, Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4550.