Model 5050 Surgilaser for Gastro-Intestinal Use
FDA 510(k) K871934 · Lasermatic, Inc.
510(k) numberK871934
Submission
- Device name
- Model 5050 Surgilaser for Gastro-Intestinal Use
- Applicant
- Lasermatic, Inc.
Dallas, TX, US - Received
- May 19, 1987
- Decision date
- March 25, 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 |
| 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 |
| 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 |
|---|---|---|
| K903131 | Lasermatic Supercombo(Tm) Surgical Laser SystemGEX · Traditional | 02/19/1991SE |
| K901638 | Modified Combolaser 5050 & New Model 5050 Ver. 33GEX · Traditional | 06/27/1990SE |
| K895279 | Lasermatic Combolaser Model 5050GEX · Traditional | 11/08/1989SE |
| K893529 | Combolaser Model 5050GEX · Traditional | 06/08/1989SE |
| K871875 | Model 5050 Surgilaser for Ob-Gyn UseHHR · Traditional | 08/22/1988SE |
| K870587 | Lasermatic Surgilaser Model 5050EWG · Traditional | 08/10/1988SN |
| K871932 | Model 5050 Surgilaser for Urology UseLNK · Traditional | 03/25/1988SE |
| K871933 | Model 5050 Surgilaser for Neurosurgery UseGEX · Traditional | 01/22/1988SE |
| K871876 | Model 5050 Surgilaser for Pulmonary UseLLO · Traditional | 01/22/1988SE |
Questions and answers
When was Model 5050 Surgilaser for Gastro-Intestinal Use cleared by the FDA?
Model 5050 Surgilaser for Gastro-Intestinal Use (K871934) received a 510(k) decision of Substantially Equivalent on March 25, 1988, 311 days after the submission was received.
What is the product code of K871934?
The FDA product code is LNK – Laser For Gastro-Urology Use, a Class II (moderate risk) device regulated under 21 CFR 878.4810.