Light, Lymphedema Reduction, Low Energy
The Light, Lymphedema Reduction, Low Energy (product code NZY) is a low-level light therapy device used as part of a therapy regimen for the treatment of post-mastectomy lymphedema, indicated as a tool to complement other therapeutic interventions for this condition. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 890.5500 within the Physical Medicine specialty. The device carries no implant or life-sustaining flags.
Basic Information
- Product Code
- NZY
- Device Class
- FDA class 2
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K030295 | LTU-904 PORTABLE LASER THERAPY UNIT | Dec 23, 2004 | Substantially Equivalent | Riancorp Pty, Ltd. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.