Laser, Ent Microsurgical Carbon-Dioxide
FDA product code EWG · Class II (moderate risk) · 21 CFR 874.4500 · Ear, Nose, Throat
24510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924652 | Benson CCA100EWG · Traditional | Benson Medical Instruments Co. | 04/09/1993SE |
| K870587 | Lasermatic Surgilaser Model 5050EWG · Traditional | Lasermatic OY | 08/10/1988SN |
| K880429 | Illumina 55 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K880428 | Illumina 25 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K880427 | Illumina 40 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K872710 | Model 20-B W/OB-10A/U Attach. for Ear, Nose/ThroatEWG · Traditional | Directed Energy, Inc. | 09/24/1987SE |
| K870840 | Model 20-C W/BR-20A/U Attach/Model HL-3.O AttachEWG · Traditional | Directed Energy, Inc. | 06/12/1987SE |
| K864975 | Laserscope Omniplus Photosurgical System for (ENT)EWG · Traditional | Laserscope | 02/25/1987SE |
| K862866 | Model 10-C W/LP-10A/U & OS-10A/U for Oral/Ent UseEWG · Traditional | Directed Energy, Inc. | 01/09/1987SE |
| K862865 | Model 10-C W/LP-10A/U & OB-10A/U for Oral/Ent UseEWG · Traditional | Directed Energy, Inc. | 01/09/1987SE |
| K862150 | Model 8-B with OS-1 Attachment (C02 Laser for ENT)EWG · Traditional | Directed Energy, Inc. | 09/04/1986SN |
| K862005 | Laserscope Omniplus Photosurgical SYSTEM/CO2 LaserEWG · Traditional | Laserscope | 08/29/1986SE |
| K860975 | Model 545-45 Laser for Ear, Nose & ThroatEWG · Traditional | Britt Corp., Inc. | 07/18/1986SE |
| K860277 | Model 525-25 Watt C02 Laser for Ear, Nose & ThroatEWG · Traditional | Britt Corp., Inc. | 05/06/1986SE |
| K854471 | Portalase 300 Carbon Dioxide Surg Laser Ear/Nose/TEWG · Traditional | Minnesota Laser Corp. | 02/13/1986SE |
| K853902 | Endo-Lase CD40 for OtorhinolaryngologyEWG · Traditional | Endo Lase, Inc. | 01/09/1986SE |
| K853875 | Endo-Lase CD-100 CO2 Laser for OtorhinolaryngologyEWG · Traditional | Endo Lase, Inc. | 01/09/1986SE |
| K852695 | For Use in Ear; Nose & Throat MicrosurgeryEWG · Traditional | Minnesota Laser Corp. | 08/30/1985SE |
| K843514 | Minuteman CO2 Microsurgical Laser OtoEWG · Traditional | American Surgical Laser, Inc. | 12/04/1984SE |
| K841860 | CO2 Surgical Laser System XML-10EWG · Traditional | Xanar, Inc. | 11/08/1984SE |
| K820535 | Laser Gas MixturesEWG · Traditional | Union Carbide Corp. | 03/31/1982SE |
| K810740 | Argon Microsurigal ProtocolsEWG · Traditional | Lumenis, Inc. | 08/21/1981SE |
| K802279 | Vida 55 Pulse-Echo Ultrasonic DeviceEWG · Traditional | Vida, Inc. | 12/15/1980SE |
| K802034 | CO2 Microsurgical Laser System #370EWG · Traditional | Metricon, Ltd. | 10/10/1980SE |