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EWG — Laser, Ent Microsurgical Carbon-Dioxide Class II

FDA Device Classification

Classification Details

Product Code
EWG
Device Class
Class II
Regulation Number
874.4500
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K924652benson medical instrumentsBENSON CCA100April 9, 1993
K870587lasermaticLASERMATIC SURGILASER MODEL 5050August 10, 1988
K880429cooper lasersonicsILLUMINA 55 CO2 LASER SYSTEMApril 18, 1988
K880427cooper lasersonicsILLUMINA 40 CO2 LASER SYSTEMApril 18, 1988
K880428cooper lasersonicsILLUMINA 25 CO2 LASER SYSTEMApril 18, 1988
K872710directed energyMODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROATSeptember 24, 1987
K870840directed energyMODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACHJune 12, 1987
K864975laserscopeLASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT)February 25, 1987
K862865directed energyMODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USEJanuary 9, 1987
K862866directed energyMODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USEJanuary 9, 1987
K862150directed energyMODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)September 4, 1986
K862005laserscopeLASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASERAugust 29, 1986
K860975britt corpMODEL 545-45 LASER FOR EAR, NOSE & THROATJuly 18, 1986
K860277britt corpMODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROATMay 6, 1986
K854471minnesota laserPORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/TFebruary 13, 1986
K853902endo laseENDO-LASE CD40 FOR OTORHINOLARYNGOLOGYJanuary 9, 1986
K853875endo laseENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGYJanuary 9, 1986
K852695minnesota laserFOR USE IN EAR; NOSE & THROAT MICROSURGERYAugust 30, 1985
K843514american surgical laserMINUTEMAN CO2 MICROSURGICAL LASER OTODecember 4, 1984
K841860xanarCO2 SURGICAL LASER SYSTEM XML-10November 8, 1984