Last synced on 12 July 2024 at 11:04 pm

Laser, Neodymium:Yag, Pulmonary Surgery

Page Type
Product Code
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.4500
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 874.4500 Ear, nose, and throat microsurgical carbon dioxide laser

§ 874.4500 Ear, nose, and throat microsurgical carbon dioxide laser.

(a) 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.

(b) Classification. Class II.

Laser, Neodymium:Yag, Pulmonary Surgery

Page Type
Product Code
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.4500
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 874.4500 Ear, nose, and throat microsurgical carbon dioxide laser

§ 874.4500 Ear, nose, and throat microsurgical carbon dioxide laser.

(a) 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.

(b) Classification. Class II.