FDA product code NZY: Light, Lymphedema Reduction, Low Energy
NZY is the FDA product code for light, lymphedema reduction, low energy. It is a Class II device, regulated under 21 CFR 890.5500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under NZY. The average 510(k) review took 695 days (median 695).
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.
Classification
| Field | Value |
|---|---|
| Device name | Light, Lymphedema Reduction, Low Energy |
| Device class | Class II |
| Regulation | 21 CFR 890.5500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NZY clearance
Top NZY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Riancorp Pty, Ltd. | 1 | 2004-12-23 |
Most recent NZY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K030295 | Riancorp Pty, Ltd. | LTU-904 PORTABLE LASER THERAPY UNIT | 2004-12-23 | 695 |
Recalls for NZY devices
openFDA lists no recalls for product code NZY.
Frequently asked questions
What is FDA product code NZY?
NZY is the FDA product code for light, lymphedema reduction, low energy. It is a Class II device, regulated under 21 CFR 890.5500 and reviewed by the General and Plastic Surgery panel.
What device class is NZY?
Class II, regulation 21 CFR 890.5500. Typical premarket route: 510(k).
How long does a 510(k) take for product code NZY?
Across 1 cleared submissions the average was 695 days from receipt to decision (median 695).
Which companies have the most NZY clearances?
Riancorp Pty, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NZY
- Run a recall and safety report across every NZY manufacturer
- Watch product code NZY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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