EWG · Laser, Ent Microsurgical Carbon-Dioxide
Ear, Nose, Throat · 21 CFR 874.4500 · Class 2
Overview
| Product Code | EWG |
|---|---|
| Device Name | Laser, Ent Microsurgical Carbon-Dioxide |
| Regulation | 21 CFR 874.4500 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| 3rd-Party Reviewable | Yes |
Identification
An ear, nose, and throat microsurgical carbon dioxide laser is a device intended for the surgical excision of tissue from the ear, nose, and throat area. The device is used, for example, in microsurgical procedures to excise lesions and tumors of the vocal cords and adjacent areas.
Classification Rationale
Class II.
Cleared Devices (24)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K924652 | BENSON CCA100 | Benson Medical Instruments Co. | Apr 9, 1993 | SESE |
| K870587 | LASERMATIC SURGILASER MODEL 5050 | Lasermatic OY | Aug 10, 1988 | SN |
| K880429 | ILLUMINA 55 CO2 LASER SYSTEM | Cooper Lasersonics, Inc. | Apr 18, 1988 | SESE |
| K880428 | ILLUMINA 25 CO2 LASER SYSTEM | Cooper Lasersonics, Inc. | Apr 18, 1988 | SESE |
| K880427 | ILLUMINA 40 CO2 LASER SYSTEM | Cooper Lasersonics, Inc. | Apr 18, 1988 | SESE |
| K872710 | MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT | Directed Energy, Inc. | Sep 24, 1987 | SESE |
| K870840 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH | Directed Energy, Inc. | Jun 12, 1987 | SESE |
| K864975 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT) | Laserscope | Feb 25, 1987 | SESE |
| K862866 | MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE | Directed Energy, Inc. | Jan 9, 1987 | SESE |
| K862865 | MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE | Directed Energy, Inc. | Jan 9, 1987 | SESE |
| K862150 | MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) | Directed Energy, Inc. | Sep 4, 1986 | SN |
| K862005 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER | Laserscope | Aug 29, 1986 | SESE |
| K860975 | MODEL 545-45 LASER FOR EAR, NOSE & THROAT | Britt Corp., Inc. | Jul 18, 1986 | SESE |
| K860277 | MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT | Britt Corp., Inc. | May 6, 1986 | SESE |
| K854471 | PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T | Minnesota Laser Corp. | Feb 13, 1986 | SESE |
| K853902 | ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY | Endo Lase, Inc. | Jan 9, 1986 | SESE |
| K853875 | ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY | Endo Lase, Inc. | Jan 9, 1986 | SESE |
| K852695 | FOR USE IN EAR; NOSE & THROAT MICROSURGERY | Minnesota Laser Corp. | Aug 30, 1985 | SESE |
| K843514 | MINUTEMAN CO2 MICROSURGICAL LASER OTO | American Surgical Laser, Inc. | Dec 4, 1984 | SESE |
| K841860 | CO2 SURGICAL LASER SYSTEM XML-10 | Xanar, Inc. | Nov 8, 1984 | SESE |
| K820535 | LASER GAS MIXTURES | Union Carbide Corp. | Mar 31, 1982 | SESE |
| K810740 | ARGON MICROSURIGAL PROTOCOLS | Lumenis, Inc. | Aug 21, 1981 | SESE |
| K802279 | VIDA 55 PULSE-ECHO ULTRASONIC DEVICE | Vida, Inc. | Dec 15, 1980 | SESE |
| K802034 | CO2 MICROSURGICAL LASER SYSTEM #370 | Metricon, Ltd. | Oct 10, 1980 | SESE |
Top Applicants
- Directed Energy, Inc. — 5 clearances
- Cooper Lasersonics, Inc. — 3 clearances
- Minnesota Laser Corp. — 2 clearances
- Laserscope — 2 clearances
- Endo Lase, Inc. — 2 clearances
