Product code LNK— General, Plastic Surgery

FDA has cleared 60 devices under product code LNK between 1983 and 1993, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19931 clearance
• 19901 clearance
• 19889 clearances
• 198716 clearances
• 198617 clearances
• 19857 clearances
• 19848 clearances
• 19831 clearance

• Laser Media8 clearances
• Cooper Lasersonics, Inc.8 clearances
• Endo Lase, Inc.6 clearances
• Sharplan Lasers, Inc.4 clearances
• Medical Energy, Inc.4 clearances
• Directed Energy, Inc.4 clearances
• Trimedyne, Inc.3 clearances
• Surgical Laser Technologies, Inc.3 clearances
• Laserscope3 clearances
• Sharplan Industries, Inc.2 clearances

• K925395 — TECHNOMED PULSOLITH 4000 LASER SYSTEMTeknomed, Inc.·1993-05-21
• K901723 — MDL-2000 LASERTRIPTERCandela Laser Corp.·1990-07-13
• K874253 — ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.Minnesota Laser Corp.·1988-07-12
• K874255 — ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.Minnesota Laser Corp.·1988-07-12
• K880193 — MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USESharplan Lasers, Inc.·1988-04-14
• K880256 — MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USESharplan Lasers, Inc.·1988-04-14
• K875039 — ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGYSurgilase, Inc.·1988-04-13
• K880171 — MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPLCooper Lasersonics, Inc.·1988-04-11
• K871932 — MODEL 5050 SURGILASER FOR UROLOGY USELasermatic, Inc.·1988-03-25
• K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USELasermatic, Inc.·1988-03-25
• K873892 — SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USELaserguide·1988-02-02
• K873330 — KTP/532 LASERLaserscope·1987-11-18
• K872870 — LASER OPTICAL FIBERS - DISPOSABLEOptimed Therapeutics·1987-10-14
• K871865 — SERIES 2900 SYNTHETIC CONTACT TIPS, GU USESharplan 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 USELaser Media·1987-08-10
• K872031 — UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEMLaser Media·1987-08-04
• K871513 — SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALIMedical Energy, Inc.·1987-07-09
• K871514 — SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOIDMedical Energy, Inc.·1987-07-09
• K871515 — SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDINGMedical Energy, Inc.·1987-07-09
• K871516 — SL-100 ND:YAG LASER FOR UROLOGIC SURGERYMedical Energy, Inc.·1987-07-09
• K871348 — SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USESharplan Lasers, Inc.·1987-06-12
• K871029 — MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.Directed Energy, Inc.·1987-05-18
• K871032 — MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.Directed Energy, Inc.·1987-05-18
• K871030 — MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.Directed Energy, Inc.·1987-05-15
• K871031 — 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRHDirected Energy, Inc.·1987-05-15
• K864948 — ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USEBio Quantum Technologies, Inc.·1987-03-30
• K863428 — SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAGLaser Media·1986-12-03
• K863583 — CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASERLaser Media·1986-11-24
• K862598 — LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEMLaserscope·1986-11-19
• K861955 — CONTACT TIPSCooper Lasersonics, Inc.·1986-08-14
• K861331 — ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBETrimedyne, Inc.·1986-08-07
• K861173 — OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTROTrimedyne, Inc.·1986-07-25
• K861903 — #6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINALCooper Lasersonics, Inc.·1986-06-20
• K861047 — MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINALSharplan Industries, Inc.·1986-06-17
• K861046 — MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICASharplan Industries, Inc.·1986-05-02
• K860357 — HGM, INC. LASERCATH (STERILE)Hgm, Inc.·1986-04-07
• K860496 — MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARYXanar, Inc.·1986-03-14
• K855100 — S.L.T. CONTACT LASER SYSTEMSurgical Laser Technologies, Inc.·1986-02-26
• K855119 — S.L.T. CONTACT LASERSurgical Laser Technologies, Inc.·1986-02-24
• K854669 — S.L.T. LASER DELIVERY SYSTEM FOR YAG LASERSurgical Laser Technologies, Inc.·1986-02-11
• K860063 — ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEMLaser Media·1986-02-05
• K860152 — MODEL 700 EVACUATOR FOR USE WITH LASER SURGERYEndo Lase, Inc.·1986-02-05
• K855197 — FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEMLaser Media·1986-01-21
• K854027 — LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEMLaserscope·1985-12-02
• K843628 — HOTIP HEMOSTATIC PROBETrimedyne, Inc.·1985-11-12
• K852798 — FIBERLASE 100 MEDICAL LASER SYSTEMLaser Media·1985-07-29
• K850509 — ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEMLaser Media·1985-04-08
• K850728 — MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEECooper Lasersonics, Inc.·1985-04-08
• K844459 — ND:YAG LASER UROLOGICAL SURGERYEndo Lase, Inc.·1985-01-16
• K844460 — ND. YAG LASER RECTAL PATHOLOGYEndo Lase, Inc.·1985-01-16
• K843240 — LASER FOR GENITOURINARY APPLIC. 4000Cooper Lasersonics, Inc.·1984-10-02
• K843293 — ND-YAG LASER FOR UROLOGICAL SURGERYEndo Lase, Inc.·1984-10-02
• K843374 — ND-YAG LASER FOR PALLIATION OF GI MALIGNEndo Lase, Inc.·1984-10-02
• K843156 — BIOLAS YAG 100 CILAS, ERCELAS YAG 100Advanced Biomedical Instruments·1984-10-01
• K841869 — COOPER LASERSONICS, 8000 ND.YAGLASERCooper Lasersonics, Inc.·1984-08-08
• K840142 — YAG LASER 8000 - LOWER GI APPLICATCooper Lasersonics, Inc.·1984-05-18
• K833499 — FIBERLAS 100 MEDICAL SYSTEMFiberlase U.S.A.·1984-04-02
• K833557 — MEDILAS LASEREndo Lase, Inc.·1984-02-07
• K833480 — MOLECTRON MEDICAL ND:YAG LASER, MODEL 8000Cooper Lasersonics, Inc.·1983-12-21