Product code EWG— Ear, Nose, Throat

FDA has cleared 24 devices under product code EWG between 1980 and 1993, filed by 14 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
• 19884 clearances
• 19875 clearances
• 19867 clearances
• 19851 clearance
• 19842 clearances
• 19821 clearance
• 19811 clearance
• 19802 clearances

• Directed Energy, Inc.5 clearances
• Cooper Lasersonics, Inc.3 clearances
• Minnesota Laser Corp.2 clearances
• Laserscope2 clearances
• Endo Lase, Inc.2 clearances
• Britt Corp., Inc.2 clearances
• Xanar, Inc.1 clearance
• Vida, Inc.1 clearance
• Union Carbide Corp.1 clearance
• Metricon, Ltd.1 clearance

• K924652 — BENSON CCA100Benson Medical Instruments Co.·1993-04-09
• K870587 — LASERMATIC SURGILASER MODEL 5050Lasermatic OY·1988-08-10
• K880427 — ILLUMINA 40 CO2 LASER SYSTEMCooper Lasersonics, Inc.·1988-04-18
• K880428 — ILLUMINA 25 CO2 LASER SYSTEMCooper Lasersonics, Inc.·1988-04-18
• K880429 — ILLUMINA 55 CO2 LASER SYSTEMCooper Lasersonics, Inc.·1988-04-18
• K872710 — MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROATDirected Energy, Inc.·1987-09-24
• K870840 — MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACHDirected Energy, Inc.·1987-06-12
• K864975 — LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT)Laserscope·1987-02-25
• K862865 — MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USEDirected Energy, Inc.·1987-01-09
• K862866 — MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USEDirected Energy, Inc.·1987-01-09
• K862150 — MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)Directed Energy, Inc.·1986-09-04
• K862005 — LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASERLaserscope·1986-08-29
• K860975 — MODEL 545-45 LASER FOR EAR, NOSE & THROATBritt Corp., Inc.·1986-07-18
• K860277 — MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROATBritt Corp., Inc.·1986-05-06
• K854471 — PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/TMinnesota Laser Corp.·1986-02-13
• K853875 — ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGYEndo Lase, Inc.·1986-01-09
• K853902 — ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGYEndo Lase, Inc.·1986-01-09
• K852695 — FOR USE IN EAR; NOSE & THROAT MICROSURGERYMinnesota Laser Corp.·1985-08-30
• K843514 — MINUTEMAN CO2 MICROSURGICAL LASER OTOAmerican Surgical Laser, Inc.·1984-12-04
• K841860 — CO2 SURGICAL LASER SYSTEM XML-10Xanar, Inc.·1984-11-08
• K820535 — LASER GAS MIXTURESUnion Carbide Corp.·1982-03-31
• K810740 — ARGON MICROSURIGAL PROTOCOLSLumenis, Inc.·1981-08-21
• K802279 — VIDA 55 PULSE-ECHO ULTRASONIC DEVICEVida, Inc.·1980-12-15
• K802034 — CO2 MICROSURGICAL LASER SYSTEM #370Metricon, Ltd.·1980-10-10