Laser For Gastro-Urology Use
FDA product code LNK · Class II (moderate risk) · 21 CFR 878.4810 · General, Plastic Surgery
60510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Laser Media 8
- Cooper Lasersonics, Inc. 8
- Endo Lase, Inc. 6
- Medical Energy, Inc. 4
- Sharplan Lasers, Inc. 4
- Directed Energy, Inc. 4
- Trimedyne, Inc. 3
- Laserscope 3
- Surgical Laser Technologies, Inc. 3
- Sharplan Industries, Inc. 2
- Minnesota Laser Corp. 2
- Lasermatic, Inc. 2
- Hgm, Inc. 2
- Bio Quantum Technologies, Inc. 1
- Xanar, Inc. 1
- Optimed Therapeutics 1
- Laserguide 1
- Advanced Biomedical Instruments 1
- Surgilase, Inc. 1
- Fiberlase U.S.A. 1
510(k) clearances
| 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 |
| K873892 | Surgi-Light Dispos.Fiberoptic Del/Sys Gi/Uro UseLNK · Traditional | Laserguide | 02/02/1988SE |
| K873330 | KTP/532 LaserLNK · Traditional | Laserscope | 11/18/1987SE |
| K872870 | Laser Optical Fibers - DisposableLNK · Traditional | Optimed Therapeutics | 10/14/1987SE |
| K871865 | Series 2900 Synthetic Contact Tips, Gu UseLNK · Traditional | Sharplan Lasers, Inc. | 09/08/1987SE |
| K872630 | Endocoagulator(Tm) Model 20 Argon Laser for Urolo.LNK · Traditional | Hgm, Inc. | 08/25/1987SE |
| K872350 | Fiberlase II Nd:Yag Laser for Gastro.&Urology UseLNK · Traditional | Laser Media | 08/10/1987SE |
| K872031 | Uni-Fiber Non-Repairable Fiber Delivery SystemLNK · Traditional | Laser Media | 08/04/1987SE |
| K871516 | SL-100 Nd:Yag Laser for Urologic SurgeryLNK · Traditional | Medical Energy, Inc. | 07/09/1987SE |
| K871515 | SL-100 Nd:Yag Laser for Gastrointestinal BleedingLNK · Traditional | Medical Energy, Inc. | 07/09/1987SE |
| K871514 | SL-100 Nd:Yag Laser for Rectal Patho. & HemorrhoidLNK · Traditional | Medical Energy, Inc. | 07/09/1987SE |
| K871513 | SL-100 Nd:Yag Laser for Palliation of Gastro. MaliLNK · Traditional | Medical Energy, Inc. | 07/09/1987SE |
| K871348 | Sharplan Medilas Model 40 N for Urological UseLNK · Traditional | Sharplan Lasers, Inc. | 06/12/1987SE |
| K871032 | Model 20-C with an SA-20A/U Opt. Attach. Hemorrho.LNK · Traditional | Directed Energy, Inc. | 05/18/1987SE |
| K871029 | Model 20-C with an SA-20B/U Opt. Attach. Hemorrho.LNK · Traditional | Directed Energy, Inc. | 05/18/1987SE |
| K871031 | 10-C/SA-10B/U Opt 20-C/20A/U Beam SA-10B/U HemorrhLNK · Traditional | Directed Energy, Inc. | 05/15/1987SE |
| K871030 | Model 10-C with an SA-10A/U Opt. Attach. Hemorrho.LNK · Traditional | Directed Energy, Inc. | 05/15/1987SE |
| K864948 | Advanced Hand Held CO2 LASER/HH-550 for DGGD UseLNK · Traditional | Bio Quantum Technologies, Inc. | 03/30/1987SE |
| K863428 | Single Use Laser Fiber Delivery System for ND: YagLNK · Traditional | Laser Media | 12/03/1986SE |
| K863583 | Change in Fiberlase 100 Nd:Yag Medical LaserLNK · Traditional | Laser Media | 11/24/1986SE |
| K862598 | Laserscope Omni Plus Photosurgical System/SupplemLNK · Traditional | Laserscope | 11/19/1986SE |
| K861955 | Contact TipsLNK · Traditional | Cooper Lasersonics, Inc. | 08/14/1986SE |
| K861331 | Endoscopic Electrosurgical Fiberoptic ProbeLNK · Traditional | Trimedyne, Inc. | 08/07/1986SE |
| K861173 | Optilase Yag Model 1000 Surg Laser System/GastroLNK · Traditional | Trimedyne, Inc. | 07/25/1986SE |
| K861903 | #6000 Nd:Yag Laser System Urology/GastrointestinalLNK · Traditional | Cooper Lasersonics, Inc. | 06/20/1986SE |
| K861047 | Model 2100 Nd:Yag Surgical Laser GastrointestinalLNK · Traditional | Sharplan Industries, Inc. | 06/17/1986SE |
| K861046 | Model 2100 Nd:Yag Surgical Laser Urological IndicaLNK · Traditional | Sharplan Industries, Inc. | 05/02/1986SE |
| K860357 | HGM, Inc. Lasercath (Sterile)LNK · Traditional | Hgm, Inc. | 04/07/1986SE |
| K860496 | Model NY-110 for Upper & Lower (Gu) & PulmonaryLNK · Traditional | Xanar, Inc. | 03/14/1986SE |
| K855100 | S.L.T. Contact Laser SystemLNK · Traditional | Surgical Laser Technologies, Inc. | 02/26/1986SE |
| K855119 | S.L.T. Contact LaserLNK · Traditional | Surgical Laser Technologies, Inc. | 02/24/1986SE |
| K854669 | S.L.T. Laser Delivery System for Yag LaserLNK · Traditional | Surgical Laser Technologies, Inc. | 02/11/1986SE |
| K860152 | Model 700 Evacuator for Use with Laser SurgeryLNK · Traditional | Endo Lase, Inc. | 02/05/1986SE |
| K860063 | Nd:Yag Laser Single Use Fiber Delivery SystemLNK · Traditional | Laser Media | 02/05/1986SE |
| K855197 | Fiberlase 100 ND: Yag Medical Laser SystemLNK · Traditional | Laser Media | 01/21/1986SE |
| K854027 | Laserscope Omni Plus Photosurgical SystemLNK · Traditional | Laserscope | 12/02/1985SE |
| K843628 | Hotip Hemostatic ProbeLNK · Traditional | Trimedyne, Inc. | 11/12/1985SE |
| K852798 | Fiberlase 100 Medical Laser SystemLNK · Traditional | Laser Media | 07/29/1985SE |
| K850728 | Model 4000 Nd:Yag Laser for Gastrointestional BleeLNK · Traditional | Cooper Lasersonics, Inc. | 04/08/1985SE |
| K850509 | Nd:Yag Fiberlase 100 Medical Laser SystemLNK · Traditional | Laser Media | 04/08/1985SE |
| K844460 | Nd. Yag Laser Rectal PathologyLNK · Traditional | Endo Lase, Inc. | 01/16/1985SE |
| K844459 | Nd:Yag Laser Urological SurgeryLNK · Traditional | Endo Lase, Inc. | 01/16/1985SE |
| K843374 | Nd-Yag Laser for Palliation of Gi MalignLNK · Traditional | Endo Lase, Inc. | 10/02/1984SE |
| K843293 | Nd-Yag Laser for Urological SurgeryLNK · Traditional | Endo Lase, Inc. | 10/02/1984SE |
| K843240 | Laser for Genitourinary Applic. 4000LNK · Traditional | Cooper Lasersonics, Inc. | 10/02/1984SE |
| K843156 | Biolas Yag 100 Cilas, Ercelas Yag 100LNK · Traditional | Advanced Biomedical Instruments | 10/01/1984SE |
| K841869 | Cooper Lasersonics, 8000 Nd.YaglaserLNK · Traditional | Cooper Lasersonics, Inc. | 08/08/1984SE |
| K840142 | Yag Laser 8000 - Lower Gi ApplicatLNK · Traditional | Cooper Lasersonics, Inc. | 05/18/1984SE |
| K833499 | Fiberlas 100 Medical SystemLNK · Traditional | Fiberlase U.S.A. | 04/02/1984SE |
| K833557 | Medilas LaserLNK · Traditional | Endo Lase, Inc. | 02/07/1984SE |
| K833480 | Molectron Medical Nd:Yag Laser, Model 8000LNK · Traditional | Cooper Lasersonics, Inc. | 12/21/1983SE |