FDA Product Code
FDA Product Code EWG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.4500
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K924652 | BENSON CCA100 | Benson Medical Instruments Co. | 1993-04-09 | Traditional | PDF ↗ |
| K870587 | LASERMATIC SURGILASER MODEL 5050 | Lasermatic OY | 1988-08-10 | Traditional | PDF ↗ |
| K880428 | ILLUMINA 25 CO2 LASER SYSTEM | Cooper Lasersonics, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K880427 | ILLUMINA 40 CO2 LASER SYSTEM | Cooper Lasersonics, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K880429 | ILLUMINA 55 CO2 LASER SYSTEM | Cooper Lasersonics, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K872710 | MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT | Directed Energy, Inc. | 1987-09-24 | Traditional | PDF ↗ |
| K870840 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH | Directed Energy, Inc. | 1987-06-12 | Traditional | PDF ↗ |
| K864975 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT) | Laserscope | 1987-02-25 | Traditional | PDF ↗ |
| K862865 | MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE | Directed Energy, Inc. | 1987-01-09 | Traditional | PDF ↗ |
| K862866 | MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE | Directed Energy, Inc. | 1987-01-09 | Traditional | PDF ↗ |
| K862150 | MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) | Directed Energy, Inc. | 1986-09-04 | Traditional | PDF ↗ |
| K862005 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER | Laserscope | 1986-08-29 | Traditional | PDF ↗ |
| K860975 | MODEL 545-45 LASER FOR EAR, NOSE & THROAT | Britt Corp., Inc. | 1986-07-18 | Traditional | PDF ↗ |
| K860277 | MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT | Britt Corp., Inc. | 1986-05-06 | Traditional | PDF ↗ |
| K854471 | PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T | Minnesota Laser Corp. | 1986-02-13 | Traditional | PDF ↗ |
| K853875 | ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY | Endo Lase, Inc. | 1986-01-09 | Traditional | PDF ↗ |
| K853902 | ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY | Endo Lase, Inc. | 1986-01-09 | Traditional | PDF ↗ |
| K852695 | FOR USE IN EAR; NOSE & THROAT MICROSURGERY | Minnesota Laser Corp. | 1985-08-30 | Traditional | PDF ↗ |
| K843514 | MINUTEMAN CO2 MICROSURGICAL LASER OTO | American Surgical Laser, Inc. | 1984-12-04 | Traditional | PDF ↗ |
| K841860 | CO2 SURGICAL LASER SYSTEM XML-10 | Xanar, Inc. | 1984-11-08 | Traditional | PDF ↗ |
| K820535 | LASER GAS MIXTURES | Union Carbide Corp. | 1982-03-31 | Traditional | PDF ↗ |
| K810740 | ARGON MICROSURIGAL PROTOCOLS | Lumenis, Inc. | 1981-08-21 | Traditional | PDF ↗ |
| K802279 | VIDA 55 PULSE-ECHO ULTRASONIC DEVICE | Vida, Inc. | 1980-12-15 | Traditional | PDF ↗ |
| K802034 | CO2 MICROSURGICAL LASER SYSTEM #370 | Metricon, Ltd. | 1980-10-10 | Traditional | PDF ↗ |
Product code EWG · Class II · Ear, Nose, Throat. Data: openFDA.