DeviceClearance

Product code LMS— Ear, Nose, Throat

ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER

Classification name
Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
Device class
Class 2
Regulation
21 CFR 874.4490
Advisory panel
Ear, Nose, Throat
Total cleared
2
First cleared
Most recent

Market context for product code LMS

FDA has cleared 2 devices under product code LMS between 1986 and 1987, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code LMS

Recent clearances under product code LMS

Data sourced from openFDA. This site is unofficial and independent of the FDA.