Product code LNK
- Device name
- Laser For Gastro-Urology Use
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4810
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K925395 | TECHNOMED PULSOLITH 4000 LASER SYSTEM | Teknomed, Inc. | 1993-05-21 |
| K901723 | MDL-2000 LASERTRIPTER | Candela Laser Corp. | 1990-07-13 |
| K874255 | ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. | Minnesota Laser Corp. | 1988-07-12 |
| K874253 | ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. | Minnesota Laser Corp. | 1988-07-12 |
| K880256 | MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE | Sharplan Lasers, Inc. | 1988-04-14 |
| K880193 | MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE | Sharplan Lasers, Inc. | 1988-04-14 |
| K875039 | ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY | Surgilase, Inc. | 1988-04-13 |
| K880171 | MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL | Cooper Lasersonics, Inc. | 1988-04-11 |
| K871934 | MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE | Lasermatic, Inc. | 1988-03-25 |
| K871932 | MODEL 5050 SURGILASER FOR UROLOGY USE | Lasermatic, Inc. | 1988-03-25 |
| K873892 | SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE | Laserguide | 1988-02-02 |
| K873330 | KTP/532 LASER | Laserscope | 1987-11-18 |
| K872870 | LASER OPTICAL FIBERS - DISPOSABLE | Optimed Therapeutics | 1987-10-14 |
| K871865 | SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE | Sharplan Lasers, Inc. | 1987-09-08 |
| K872630 | ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. | Hgm, Inc. | 1987-08-25 |
| K872350 | FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE | Laser Media | 1987-08-10 |
| K872031 | UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM | Laser Media | 1987-08-04 |
| K871514 | SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID | Medical Energy, Inc. | 1987-07-09 |
| K871513 | SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI | Medical Energy, Inc. | 1987-07-09 |
| K871515 | SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING | Medical Energy, Inc. | 1987-07-09 |
| K871516 | SL-100 ND:YAG LASER FOR UROLOGIC SURGERY | Medical Energy, Inc. | 1987-07-09 |
| K871348 | SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE | Sharplan Lasers, Inc. | 1987-06-12 |
| K871032 | MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO. | Directed Energy, Inc. | 1987-05-18 |
| K871029 | MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO. | Directed Energy, Inc. | 1987-05-18 |
| K871031 | 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH | Directed Energy, Inc. | 1987-05-15 |
| K871030 | MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO. | Directed Energy, Inc. | 1987-05-15 |
| K864948 | ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE | Bio Quantum Technologies, Inc. | 1987-03-30 |
| K863428 | SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG | Laser Media | 1986-12-03 |
| K863583 | CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER | Laser Media | 1986-11-24 |
| K862598 | LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM | Laserscope | 1986-11-19 |
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