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

Laser, Neodymium:Yag For Gynecologic Use

21 CFR 884.4550 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

LLW is the FDA product code for Laser, Neodymium:Yag For Gynecologic Use, a class II device type, regulated under 21 CFR 884.4550. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
LLW
Device name
Laser, Neodymium:Yag For Gynecologic Use
Regulation
21 CFR 884.4550
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code LLW

By decision year
1 clearance under product code LLW with a decision year between 1985 and 1985, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LLW by decision year
YearClearances
19851

Applicants with the most clearances

Product code LLW
Applicants holding the most 510(k) clearances under product code LLW
ApplicantClearances
Vital Signs, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LLW.