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
NZYClass II

Light, Lymphedema Reduction, Low Energy

21 CFR 890.5500 / Physical Medicine
FDA source (opens on fda.gov)

NZY is the FDA product code for Light, Lymphedema Reduction, Low Energy, a class II device type, regulated under 21 CFR 890.5500. FDA's definition for this code reads: "Intended for use as a tool as part of a therapy regime for the low level light treatment of post mastectomy lymphedema and indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NZY
Device name
Light, Lymphedema Reduction, Low Energy
FDA definition
Intended for use as a tool as part of a therapy regime for the low level light treatment of post mastectomy lymphedema and indicated for use as a tool as part of a therapy regime for the treatment of post mastectomy lymphedema.
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code NZY

By decision year
1 clearance under product code NZY with a decision year between 2004 and 2004, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NZY by decision year
YearClearances
20041

Applicants with the most clearances

Product code NZY
Applicants holding the most 510(k) clearances under product code NZY
ApplicantClearances
Riancorp Pty Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code