Laser, Ent Microsurgical Carbon-dioxide
Product Code: EWG
Ear Nose & Throat Medical Laser Products
Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]
Code of Federal Regulations: 874.4500
| Radiation Type | Optical |
| Radition Safety | Product |
| Annual Reports | Yes |
| K924652 | BENSON CCA100 | BENSON MEDICAL INSTRUMENTS CO. |
| K880428 | ILLUMINA 25 CO2 LASER SYSTEM | COOPER LASERSONICS, INC. |
| K880427 | ILLUMINA 40 CO2 LASER SYSTEM | COOPER LASERSONICS, INC. |
| K880429 | ILLUMINA 55 CO2 LASER SYSTEM | COOPER LASERSONICS, INC. |
| K872710 | MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT | DIRECTED ENERGY, INC. |
| K870840 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH | DIRECTED ENERGY, INC. |
| K870587 | LASERMATIC SURGILASER MODEL 5050 | LASERMATIC OY |
| K864975 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT) | LASERSCOPE |
| K862865 | MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE | DIRECTED ENERGY, INC. |
| K862866 | MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE | DIRECTED ENERGY, INC. |
| K862150 | MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) | DIRECTED ENERGY, INC. |
| K862005 | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER | LASERSCOPE |
| K860975 | MODEL 545-45 LASER FOR EAR, NOSE & THROAT | BRITT CORP., INC. |
| K860277 | MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT | BRITT CORP., INC. |
| K854471 | PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T | MINNESOTA LASER CORP. |