NZY — Light, Lymphedema Reduction, Low Energy Class II
FDA product code NZY covers "Light, Lymphedema Reduction, Low Energy", a Class II medical device regulated under 21 CFR 890.5500. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NZY
- Device Class
- Class II
- Regulation Number
- 890.5500
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Physical Medicine
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K030295 | riancorp pty | LTU-904 PORTABLE LASER THERAPY UNIT | December 23, 2004 |