DeviceClearance

Product code NZY— Physical Medicine

LTU-904 PORTABLE LASER THERAPY UNIT

Classification name
Light, Lymphedema Reduction, Low Energy
Device class
Class 2
Regulation
21 CFR 890.5500
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NZY under 21 CFR 890.5500, via openFDA

Market context for product code NZY

FDA has cleared 1 device under product code NZY, all in 2004, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NZY

Recent clearances under product code NZY

Data sourced from openFDA. This site is unofficial and independent of the FDA.