510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
LXSClass II

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

21 CFR 886.4392 / Ophthalmic
FDA source (opens on fda.gov)

LXS is the FDA product code for Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla, a class II device type, regulated under 21 CFR 886.4392. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LXS
Device name
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Regulation
21 CFR 886.4392
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
1

Clearances, product code LXS

By decision year
6 clearances under product code LXS with a decision year between 1989 and 2002, 1989 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LXS by decision year
YearClearances
19894
19901
20021

Applicants with the most clearances

Product code LXS
Applicants holding the most 510(k) clearances under product code LXS
ApplicantClearances
Nidek, Inc.2
Intelligent Surgical Lasers, Inc.1
Lasag AG1
Meridian AG1
Phoenix Laser Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code