Laser for Genitourinary Applic. 4000
FDA 510(k) K843240 · Cooper Lasersonics, Inc.
510(k) numberK843240
Submission
- Device name
- Laser for Genitourinary Applic. 4000
- Applicant
- Cooper Lasersonics, Inc.
Mchenry, IL, US - Received
- August 22, 1984
- Decision date
- October 2, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LNK – Laser For Gastro-Urology Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code LNK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K925395 | Technomed Pulsolith 4000 Laser SystemLNK · Traditional | Teknomed, Inc. | 05/21/1993SE |
| K901723 | MDL-2000 LasertripterLNK · Traditional | Candela Laser Corp. | 07/13/1990SE |
| K874255 | Nd:Yag Surgical Laser for Endo. Gastro/Uro. Appli.LNK · Traditional | Minnesota Laser Corp. | 07/12/1988SE |
| K874253 | Nd:Yag Surgical Laser for Gastro/Urology Applica.LNK · Traditional | Minnesota Laser Corp. | 07/12/1988SE |
| K880256 | Model 4060 N Nd:Yag Laser for Gastroenterology UseLNK · Traditional | Sharplan Lasers, Inc. | 04/14/1988SE |
| K880193 | Model 4060 N Nd:Yag Laser for Urological UseLNK · Traditional | Sharplan Lasers, Inc. | 04/14/1988SE |
| K875039 | Nd:Yag 100 Surgical Laser for Gastro. and UrologyLNK · Traditional | Surgilase, Inc. | 04/13/1988SE |
| K880171 | Model 4900 Nd:Yag Laser for Gastro & Genitour ApplLNK · Traditional | Cooper Lasersonics, Inc. | 04/11/1988SE |
| K871934 | Model 5050 Surgilaser for Gastro-Intestinal UseLNK · Traditional | Lasermatic, Inc. | 03/25/1988SE |
| K871932 | Model 5050 Surgilaser for Urology UseLNK · Traditional | Lasermatic, Inc. | 03/25/1988SE |
More from Lasermatic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880809 | Illumina Model 55 CO2 Laser for General/Plastic SuGEX · Traditional | 04/18/1988SE |
| K880808 | Illumina Model 40 CO2 Laser for General/Plastic SuGEX · Traditional | 04/18/1988SE |
| K880807 | Illumina Model 25 CO2 Laser for General/Plastic SuGEX · Traditional | 04/18/1988SE |
| K880429 | Illumina 55 CO2 Laser SystemEWG · Traditional | 04/18/1988SE |
| K880428 | Illumina 25 CO2 Laser SystemEWG · Traditional | 04/18/1988SE |
| K880427 | Illumina 40 CO2 Laser SystemEWG · Traditional | 04/18/1988SE |
| K880171 | Model 4900 Nd:Yag Laser for Gastro & Genitour ApplLNK · Traditional | 04/11/1988SE |
| K880173 | Model 4900 Nd:Yag Laser for Endometrial AblationHHR · Traditional | 03/24/1988SE |
| K880170 | Model 4900 Nd:Yag Laser for Pulmonary ObstructionsLLO · Traditional | 03/24/1988SE |
| K880172 | Model 4900 Nd:Yag Laser for Neurosurgery Applica.LKW · Traditional | 03/11/1988SE |
Questions and answers
When was Laser for Genitourinary Applic. 4000 cleared by the FDA?
Laser for Genitourinary Applic. 4000 (K843240) received a 510(k) decision of Substantially Equivalent on October 2, 1984, 41 days after the submission was received.
What is the product code of K843240?
The FDA product code is LNK – Laser For Gastro-Urology Use, a Class II (moderate risk) device regulated under 21 CFR 878.4810.