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

Laser, Neodymium:Yag, Pulmonary Surgery

21 CFR 874.4500 / Ear, Nose, Throat
FDA source (opens on fda.gov)

LLO is the FDA product code for Laser, Neodymium:Yag, Pulmonary Surgery, a class II device type, regulated under 21 CFR 874.4500. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LLO
Device name
Laser, Neodymium:Yag, Pulmonary Surgery
Regulation
21 CFR 874.4500
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
19
Ingested recalls
0

Clearances, product code LLO

By decision year
19 clearances under product code LLO with a decision year between 1985 and 1988, 1988 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code LLO by decision year
YearClearances
19854
19865
19873
19887

Applicants with the most clearances

Product code LLO
Applicants holding the most 510(k) clearances under product code LLO
ApplicantClearances
Cooper Lasersonics, Inc.3
Laser Media2
Surgical Laser Technologies, Inc.2
Endo Lase, Inc.1
Inframed, Inc.1
Laser Peripherals LLC1
Laserguide1
Lasermatic, Inc.1
Medical Energy, Inc.1
Minnesota Laser Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code