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

Laser For Gastro-Urology Use

21 CFR 878.4810 / General, Plastic Surgery
FDA source (opens on fda.gov)

LNK is the FDA product code for Laser For Gastro-Urology Use, a class II device type, regulated under 21 CFR 878.4810. As of , FDA records hold 60 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LNK
Device name
Laser For Gastro-Urology Use
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
60
Ingested recalls
0

Clearances, product code LNK

By decision year
60 clearances under product code LNK with a decision year between 1983 and 1993, 1986 the highest year at 17.
Show the numbers
510(k) clearances under FDA product code LNK by decision year
YearClearances
19831
19848
19857
198617
198716
19889
19901
19931

Applicants with the most clearances

Product code LNK
Applicants holding the most 510(k) clearances under product code LNK
ApplicantClearances
Cooper Lasersonics, Inc.8
Laser Media8
Endo Lase, Inc.6
Directed Energy, Inc.4
Medical Energy, Inc.4
Sharplan Lasers, Inc.4
Laserscope3
Surgical Laser Technologies, Inc.3
Trimedyne, Inc.3
Hgm, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code