FDA Product Code
FDA Product Code LNK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4810
510(k) Clearances — 60 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K925395 | TECHNOMED PULSOLITH 4000 LASER SYSTEM | Teknomed, Inc. | 1993-05-21 | Traditional | PDF ↗ |
| K901723 | MDL-2000 LASERTRIPTER | Candela Laser Corp. | 1990-07-13 | Traditional | PDF ↗ |
| K874253 | ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. | Minnesota Laser Corp. | 1988-07-12 | Traditional | PDF ↗ |
| K874255 | ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. | Minnesota Laser Corp. | 1988-07-12 | Traditional | PDF ↗ |
| K880193 | MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE | Sharplan Lasers, Inc. | 1988-04-14 | Traditional | PDF ↗ |
| K880256 | MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE | Sharplan Lasers, Inc. | 1988-04-14 | Traditional | PDF ↗ |
| K875039 | ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY | Surgilase, Inc. | 1988-04-13 | Traditional | PDF ↗ |
| K880171 | MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL | Cooper Lasersonics, Inc. | 1988-04-11 | Traditional | PDF ↗ |
| K871934 | MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE | Lasermatic, Inc. | 1988-03-25 | Traditional | PDF ↗ |
| K871932 | MODEL 5050 SURGILASER FOR UROLOGY USE | Lasermatic, Inc. | 1988-03-25 | Traditional | PDF ↗ |
| K873892 | SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE | Laserguide | 1988-02-02 | Traditional | PDF ↗ |
| K873330 | KTP/532 LASER | Laserscope | 1987-11-18 | Traditional | PDF ↗ |
| K872870 | LASER OPTICAL FIBERS - DISPOSABLE | Optimed Therapeutics | 1987-10-14 | Traditional | PDF ↗ |
| K871865 | SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE | Sharplan Lasers, Inc. | 1987-09-08 | Traditional | PDF ↗ |
| K872630 | ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. | Hgm, Inc. | 1987-08-25 | Traditional | PDF ↗ |
| K872350 | FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE | Laser Media | 1987-08-10 | Traditional | PDF ↗ |
| K872031 | UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM | Laser Media | 1987-08-04 | Traditional | PDF ↗ |
| K871515 | SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING | Medical Energy, Inc. | 1987-07-09 | Traditional | PDF ↗ |
| K871513 | SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI | Medical Energy, Inc. | 1987-07-09 | Traditional | PDF ↗ |
| K871516 | SL-100 ND:YAG LASER FOR UROLOGIC SURGERY | Medical Energy, Inc. | 1987-07-09 | Traditional | PDF ↗ |
| K871514 | SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID | Medical Energy, Inc. | 1987-07-09 | Traditional | PDF ↗ |
| K871348 | SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE | Sharplan Lasers, Inc. | 1987-06-12 | Traditional | PDF ↗ |
| K871032 | MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO. | Directed Energy, Inc. | 1987-05-18 | Traditional | PDF ↗ |
| K871029 | MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO. | Directed Energy, Inc. | 1987-05-18 | Traditional | PDF ↗ |
| K871031 | 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH | Directed Energy, Inc. | 1987-05-15 | Traditional | PDF ↗ |
| K871030 | MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO. | Directed Energy, Inc. | 1987-05-15 | Traditional | PDF ↗ |
| K864948 | ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE | Bio Quantum Technologies, Inc. | 1987-03-30 | Traditional | PDF ↗ |
| K863428 | SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG | Laser Media | 1986-12-03 | Traditional | PDF ↗ |
| K863583 | CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER | Laser Media | 1986-11-24 | Traditional | PDF ↗ |
| K862598 | LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM | Laserscope | 1986-11-19 | Traditional | PDF ↗ |
| K861955 | CONTACT TIPS | Cooper Lasersonics, Inc. | 1986-08-14 | Traditional | PDF ↗ |
| K861331 | ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE | Trimedyne, Inc. | 1986-08-07 | Traditional | PDF ↗ |
| K861173 | OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO | Trimedyne, Inc. | 1986-07-25 | Traditional | PDF ↗ |
| K861903 | #6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL | Cooper Lasersonics, Inc. | 1986-06-20 | Traditional | PDF ↗ |
| K861047 | MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL | Sharplan Industries, Inc. | 1986-06-17 | Traditional | PDF ↗ |
| K861046 | MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA | Sharplan Industries, Inc. | 1986-05-02 | Traditional | PDF ↗ |
| K860357 | HGM, INC. LASERCATH (STERILE) | Hgm, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K860496 | MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY | Xanar, Inc. | 1986-03-14 | Traditional | PDF ↗ |
| K855100 | S.L.T. CONTACT LASER SYSTEM | Surgical Laser Technologies, Inc. | 1986-02-26 | Traditional | PDF ↗ |
| K855119 | S.L.T. CONTACT LASER | Surgical Laser Technologies, Inc. | 1986-02-24 | Traditional | PDF ↗ |
| K854669 | S.L.T. LASER DELIVERY SYSTEM FOR YAG LASER | Surgical Laser Technologies, Inc. | 1986-02-11 | Traditional | PDF ↗ |
| K860063 | ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM | Laser Media | 1986-02-05 | Traditional | PDF ↗ |
| K860152 | MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY | Endo Lase, Inc. | 1986-02-05 | Traditional | PDF ↗ |
| K855197 | FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM | Laser Media | 1986-01-21 | Traditional | PDF ↗ |
| K854027 | LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM | Laserscope | 1985-12-02 | Traditional | PDF ↗ |
| K843628 | HOTIP HEMOSTATIC PROBE | Trimedyne, Inc. | 1985-11-12 | Traditional | PDF ↗ |
| K852798 | FIBERLASE 100 MEDICAL LASER SYSTEM | Laser Media | 1985-07-29 | Traditional | PDF ↗ |
| K850728 | MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE | Cooper Lasersonics, Inc. | 1985-04-08 | Traditional | PDF ↗ |
| K850509 | ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM | Laser Media | 1985-04-08 | Traditional | PDF ↗ |
| K844460 | ND. YAG LASER RECTAL PATHOLOGY | Endo Lase, Inc. | 1985-01-16 | Traditional | PDF ↗ |
| K844459 | ND:YAG LASER UROLOGICAL SURGERY | Endo Lase, Inc. | 1985-01-16 | Traditional | PDF ↗ |
| K843293 | ND-YAG LASER FOR UROLOGICAL SURGERY | Endo Lase, Inc. | 1984-10-02 | Traditional | PDF ↗ |
| K843240 | LASER FOR GENITOURINARY APPLIC. 4000 | Cooper Lasersonics, Inc. | 1984-10-02 | Traditional | PDF ↗ |
| K843374 | ND-YAG LASER FOR PALLIATION OF GI MALIGN | Endo Lase, Inc. | 1984-10-02 | Traditional | PDF ↗ |
| K843156 | BIOLAS YAG 100 CILAS, ERCELAS YAG 100 | Advanced Biomedical Instruments | 1984-10-01 | Traditional | PDF ↗ |
| K841869 | COOPER LASERSONICS, 8000 ND.YAGLASER | Cooper Lasersonics, Inc. | 1984-08-08 | Traditional | PDF ↗ |
| K840142 | YAG LASER 8000 - LOWER GI APPLICAT | Cooper Lasersonics, Inc. | 1984-05-18 | Traditional | PDF ↗ |
| K833499 | FIBERLAS 100 MEDICAL SYSTEM | Fiberlase U.S.A. | 1984-04-02 | Traditional | PDF ↗ |
| K833557 | MEDILAS LASER | Endo Lase, Inc. | 1984-02-07 | Traditional | PDF ↗ |
| K833480 | MOLECTRON MEDICAL ND:YAG LASER, MODEL 8000 | Cooper Lasersonics, Inc. | 1983-12-21 | Traditional | PDF ↗ |
Product code LNK · Class II · General, Plastic Surgery. Data: openFDA.