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HHR — Laser, Surgical, Gynecologic Class II

FDA Device Classification

Classification Details

Product Code
HHR
Device Class
Class II
Regulation Number
884.4550
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K881507hgm medical laser systemsENDOCOAGULATOR MODEL 20 LASER & ACCESSORIESApril 27, 1989
K871875lasermaticMODEL 5050 SURGILASER FOR OB-GYN USEAugust 22, 1988
K875314laser engineeringGL-35 COLPOSCOPIC LASER SYSTEMAugust 5, 1988
K874615medical marketingLASER CANNISTER FILTERJune 23, 1988
K880591laser peripheralsLASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USEJune 1, 1988
K880930copper lasersonicsMDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASEMay 31, 1988
K880991medline industriesLASER OPTICAL CATHETER SYSTEMMay 25, 1988
K880173cooper lasersonicsMODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATIONMarch 24, 1988
K874837laserscopeKTP/532 LASER FOR OB-GYN USEMarch 14, 1988
K875078w.c. heraeusHERACURE LS 500February 22, 1988
K870841directed energyMODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYNFebruary 2, 1988
K872709directed energyMODEL 20-C, RL-20A/U, OB-10A/UFebruary 2, 1988
K864946bio quantum technologiesADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USEJanuary 28, 1988
K872352laser mediaFIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIADecember 30, 1987
K872254surgical laser technologiesSLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITALDecember 14, 1987
K871579sharplan lasersMODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USENovember 16, 1987
K872253surgical laser technologiesCONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIAOctober 6, 1987
K871220cooper lasersonicsMODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.July 16, 1987
K870046tti medicalDOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SETMarch 5, 1987
K864378transamerican technologies intlCO2 LASER MICROMANIPULATORMarch 5, 1987