510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K855146Substantially Equivalent

Laserscope Omniplus Photosurgical Syst/nd:yag Otol

Laserscope, Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K855146 is the FDA 510(k) clearance record for LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL, a class II device, cleared for Laserscope on under FDA product code LMS (Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology). FDA records list 60 510(k) clearances for Laserscope, from to . As of , FDA records show no recalls naming K855146.

Clearance record

Decision date
Received
(108 days to decision)
Product code
LMS Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
Regulation
21 CFR 874.4490
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Laserscope 3350 Scott Blvd., Bldg.30, Santa Clara CA
Third party review
No

Clearances, product code LMS

Trailing 12 months

FDA records hold no clearances under product code LMS in the trailing twelve months.

FDA records show no clearances under product code LMS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LMS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260