S.L.T. Laser Delivery System for Yag Laser
FDA 510(k) K854669 · Surgical Laser Technologies, Inc.
510(k) numberK854669
Submission
- Device name
- S.L.T. Laser Delivery System for Yag Laser
- Applicant
- Surgical Laser Technologies, Inc.
Cincinnati, OH, US - Received
- November 21, 1985
- Decision date
- February 11, 1986
- 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 |
|---|---|---|
| K042211 | Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsGEX · Traditional | 11/08/2004SE |
| K023624 | SLT Venous Fiber Delivery Systems, Model: 0041-6772/0041-6781/0041-6752/0041-6761/0041-69…GEX · Traditional | 01/27/2003SE |
| K011409 | SLT Laserpro CTH Holmium Laser SystemGEX · Traditional | 06/14/2001SE |
| K010041 | SLT Diffuser FiberGEX · Traditional | 03/07/2001SE |
| K984018 | Hemosleeve, Model 4.0MM, 5.5MMGEI · Traditional | 03/15/1999SE |
| K983050 | Pneumatic Cutter SystemERL · Traditional | 11/25/1998SE |
| K981041 | SLT Bipolar SheathERL · Traditional | 08/27/1998SE |
| K972548 | SLT CL MD Contact Laser SystemGEX · Traditional | 04/21/1998SE |
| K980156 | SLT Select Fiber Delivery System and Contact TipsGEX · Traditional | 02/27/1998SE |
| K960821 | SLT Fumich Probe GuideGEX · Traditional | 05/16/1996SE |
Questions and answers
When was S.L.T. Laser Delivery System for Yag Laser cleared by the FDA?
S.L.T. Laser Delivery System for Yag Laser (K854669) received a 510(k) decision of Substantially Equivalent on February 11, 1986, 82 days after the submission was received.
What is the product code of K854669?
The FDA product code is LNK – Laser For Gastro-Urology Use, a Class II (moderate risk) device regulated under 21 CFR 878.4810.