LNK — Laser For Gastro-Urology Use Class II
FDA product code LNK covers "Laser For Gastro-Urology Use", a Class II medical device regulated under 21 CFR 878.4810. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LNK
- Device Class
- Class II
- Regulation Number
- 878.4810
- Submission Type
- Review Panel
- GU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K925395 | teknomed | TECHNOMED PULSOLITH 4000 LASER SYSTEM | May 21, 1993 |
| K901723 | candela laser | MDL-2000 LASERTRIPTER | July 13, 1990 |
| K874253 | minnesota laser | ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. | July 12, 1988 |
| K874255 | minnesota laser | ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. | July 12, 1988 |
| K880256 | sharplan lasers | MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE | April 14, 1988 |
| K880193 | sharplan lasers | MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE | April 14, 1988 |
| K875039 | surgilase | ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY | April 13, 1988 |
| K880171 | cooper lasersonics | MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL | April 11, 1988 |
| K871932 | lasermatic | MODEL 5050 SURGILASER FOR UROLOGY USE | March 25, 1988 |
| K871934 | lasermatic | MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE | March 25, 1988 |
| K873892 | laserguide | SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE | February 2, 1988 |
| K873330 | laserscope | KTP/532 LASER | November 18, 1987 |
| K872870 | optimed therapeutics | LASER OPTICAL FIBERS - DISPOSABLE | October 14, 1987 |
| K871865 | sharplan lasers | SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE | September 8, 1987 |
| K872630 | hgm | ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. | August 25, 1987 |
| K872350 | laser media | FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE | August 10, 1987 |
| K872031 | laser media | UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM | August 4, 1987 |
| K871513 | medical energy | SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI | July 9, 1987 |
| K871516 | medical energy | SL-100 ND:YAG LASER FOR UROLOGIC SURGERY | July 9, 1987 |
| K871515 | medical energy | SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING | July 9, 1987 |