CO2 Laser Micromanipulator
FDA 510(k) K864378 · Transamerican Technologies Intl.
510(k) numberK864378
Submission
- Device name
- CO2 Laser Micromanipulator
- Applicant
- Transamerican Technologies Intl.
Lafayette, CA, US - Received
- November 5, 1986
- Decision date
- March 5, 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 |
|---|---|---|
| K971677 | Accu-Surg Bi-Polar Electrodes, L-Hook, Needle, Ball, Bipolar CordGEI · Traditional | 08/20/1997SE |
| K963193 | Accu-Beam Laser Block 301513BG385/BEAM Splitters 301513BG39GEX · Traditional | 11/13/1996SE |
| K934398 | Accu-Beam Tissue Drill & Aspiration/Injection NeedleGCJ · Traditional | 02/14/1994SE |
Questions and answers
When was CO2 Laser Micromanipulator cleared by the FDA?
CO2 Laser Micromanipulator (K864378) received a 510(k) decision of Substantially Equivalent on March 5, 1987, 120 days after the submission was received.
What is the product code of K864378?
The FDA product code is HHR – Laser, Surgical, Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4550.