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LNK — Laser For Gastro-Urology Use Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K925395teknomedTECHNOMED PULSOLITH 4000 LASER SYSTEMMay 21, 1993
K901723candela laserMDL-2000 LASERTRIPTERJuly 13, 1990
K874253minnesota laserND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.July 12, 1988
K874255minnesota laserND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.July 12, 1988
K880256sharplan lasersMODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USEApril 14, 1988
K880193sharplan lasersMODEL 4060 N ND:YAG LASER FOR UROLOGICAL USEApril 14, 1988
K875039surgilaseND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGYApril 13, 1988
K880171cooper lasersonicsMODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPLApril 11, 1988
K871934lasermaticMODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USEMarch 25, 1988
K871932lasermaticMODEL 5050 SURGILASER FOR UROLOGY USEMarch 25, 1988
K873892laserguideSURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USEFebruary 2, 1988
K873330laserscopeKTP/532 LASERNovember 18, 1987
K872870optimed therapeuticsLASER OPTICAL FIBERS - DISPOSABLEOctober 14, 1987
K871865sharplan lasersSERIES 2900 SYNTHETIC CONTACT TIPS, GU USESeptember 8, 1987
K872630hgmENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.August 25, 1987
K872350laser mediaFIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USEAugust 10, 1987
K872031laser mediaUNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEMAugust 4, 1987
K871514medical energySL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOIDJuly 9, 1987
K871513medical energySL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALIJuly 9, 1987
K871516medical energySL-100 ND:YAG LASER FOR UROLOGIC SURGERYJuly 9, 1987