21 CFR 874.4500 — Laser, Ent Microsurgical Carbon-Dioxide
Ear, Nose, Throat (EN) · Part 874 Subpart E—Surgical Devices · § 874.4500
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | 2 | 24 | 3rd Party |
| LLO | Laser, Neodymium:Yag, Pulmonary Surgery | 2 | 19 | 3rd Party |
