EWG — Laser, Ent Microsurgical Carbon-Dioxide Class II
FDA product code EWG covers "Laser, Ent Microsurgical Carbon-Dioxide", a Class II medical device regulated under 21 CFR 874.4500. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K924652 | benson medical instruments | BENSON CCA100 | April 9, 1993 |
| K870587 | lasermatic | LASERMATIC SURGILASER MODEL 5050 | August 10, 1988 |
| K880427 | cooper lasersonics | ILLUMINA 40 CO2 LASER SYSTEM | April 18, 1988 |
| K880429 | cooper lasersonics | ILLUMINA 55 CO2 LASER SYSTEM | April 18, 1988 |
| K880428 | cooper lasersonics | ILLUMINA 25 CO2 LASER SYSTEM | April 18, 1988 |
| K872710 | directed energy | MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT | September 24, 1987 |
| K870840 | directed energy | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH | June 12, 1987 |
| K864975 | laserscope | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT) | February 25, 1987 |
| K862865 | directed energy | MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE | January 9, 1987 |
| K862866 | directed energy | MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE | January 9, 1987 |
| K862150 | directed energy | MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) | September 4, 1986 |
| K862005 | laserscope | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER | August 29, 1986 |
| K860975 | britt corp | MODEL 545-45 LASER FOR EAR, NOSE & THROAT | July 18, 1986 |
| K860277 | britt corp | MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT | May 6, 1986 |
| K854471 | minnesota laser | PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T | February 13, 1986 |
| K853875 | endo lase | ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY | January 9, 1986 |
| K853902 | endo lase | ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY | January 9, 1986 |
| K852695 | minnesota laser | FOR USE IN EAR; NOSE & THROAT MICROSURGERY | August 30, 1985 |
| K843514 | american surgical laser | MINUTEMAN CO2 MICROSURGICAL LASER OTO | December 4, 1984 |
| K841860 | xanar | CO2 SURGICAL LASER SYSTEM XML-10 | November 8, 1984 |