Model 545-45 Laser for Ear, Nose & Throat

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K860975 ↗

FDA Product Code

EWG

Models / Variants

545-45 Laser For Ear

Nose

Throat

Device Class

Class II

Regulation

21 CFR Part 874.4500

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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