Nd:Yag Surgical Laser for Gastro/Urology Applica.
FDA 510(k) K874253 · Minnesota Laser Corp.
510(k) numberK874253
Submission
- Device name
- Nd:Yag Surgical Laser for Gastro/Urology Applica.
- Applicant
- Minnesota Laser Corp.
Minneapolis, MN, US - Received
- October 20, 1987
- Decision date
- July 12, 1988
- 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 |
| 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 |
| K873892 | Surgi-Light Dispos.Fiberoptic Del/Sys Gi/Uro UseLNK · Traditional | Laserguide | 02/02/1988SE |
More from Laserguide
| 510(k) | Device | Decision |
|---|---|---|
| K874255 | Nd:Yag Surgical Laser for Endo. Gastro/Uro. Appli.LNK · Traditional | 07/12/1988SE |
| K874254 | Nd:Yag Surgical Laser for Pulmonary ApplicationsLLO · Traditional | 03/04/1988SE |
| K854473 | Portalase 300 Carbon Dioxide Surg Laser NeurologicGEX · Traditional | 06/20/1986SE |
| K854468 | Portalase 200 Carbon Dioxide Surg Laser NeurologicGEX · Traditional | 06/20/1986SE |
| K854471 | Portalase 300 Carbon Dioxide Surg Laser Ear/Nose/TEWG · Traditional | 02/13/1986SE |
| K854472 | Portalase 300 Carbon Dioxide Surg Laser DermatologGEX · Traditional | 02/11/1986SE |
| K854469 | Portalase 200 Carbon Dioxide Surg Laser DermatologGEX · Traditional | 02/11/1986SE |
| K854470 | Portalase 300 Carbon Dioxide Surg Laser GynecologiHHR · Traditional | 02/07/1986SE |
| K852694 | Portalase 200 Carbon Surgical Laser SystemHHR · Traditional | 09/30/1985SN |
| K852696 | For Use in General & Plastic Surgery & DermatologyGEX · Traditional | 09/19/1985SE |
Questions and answers
When was Nd:Yag Surgical Laser for Gastro/Urology Applica. cleared by the FDA?
Nd:Yag Surgical Laser for Gastro/Urology Applica. (K874253) received a 510(k) decision of Substantially Equivalent on July 12, 1988, 266 days after the submission was received.
What is the product code of K874253?
The FDA product code is LNK – Laser For Gastro-Urology Use, a Class II (moderate risk) device regulated under 21 CFR 878.4810.