Endo-Lase CD40 CO2 for Gynecology
FDA 510(k) K853903 · Endo Lase, Inc.
510(k) numberK853903
Submission
- Device name
- Endo-Lase CD40 CO2 for Gynecology
- Applicant
- Endo Lase, Inc.
Washington, DC, US - Received
- September 20, 1985
- Decision date
- February 21, 1986
- 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 |
|---|---|---|
| K853900 | Endo-Lase CD40 for NeurosurgeryGEX · Traditional | 06/18/1986SE |
| K853878 | Endo-Lase CD-100 CO2 Laser for NeurosurgeryGEX · Traditional | 05/02/1986SE |
| K855093 | Medilas 2 Nd:Yag Laser Surgery SystemHHR · Traditional | 02/21/1986SE |
| K853876 | Endo-Lse CD-100 CO2 Laser for GynecologyHHR · Traditional | 02/21/1986SE |
| K853901 | Endo-Lase CD 40 for DermatologyGEX · Traditional | 02/19/1986SE |
| K853877 | Endo-Lase CD-100 CO2 Laser for DermatologyGEX · Traditional | 02/19/1986SE |
| K853580 | Medilas 2LKW · Traditional | 02/13/1986SE |
| K860152 | Model 700 Evacuator for Use with Laser SurgeryLNK · Traditional | 02/05/1986SE |
| K853902 | Endo-Lase CD40 for OtorhinolaryngologyEWG · Traditional | 01/09/1986SE |
| K853875 | Endo-Lase CD-100 CO2 Laser for OtorhinolaryngologyEWG · Traditional | 01/09/1986SE |
Questions and answers
When was Endo-Lase CD40 CO2 for Gynecology cleared by the FDA?
Endo-Lase CD40 CO2 for Gynecology (K853903) received a 510(k) decision of Substantially Equivalent on February 21, 1986, 154 days after the submission was received.
What is the product code of K853903?
The FDA product code is HHR – Laser, Surgical, Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4550.