FDA product code NUV: Massager, Vacuum, Light Induced Heating
NUV is the FDA product code for massager, vacuum, light induced heating. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. FDA has cleared 20 510(k) submissions under NUV, 2 in the last five years, from 14 different applicants. The average 510(k) review took 113 days (median 110); 107 days on average over the last three years.
Definition
The device is intended to temporarily alter the appearance of cellulite
Classification
| Field | Value |
|---|---|
| Device name | Massager, Vacuum, Light Induced Heating |
| Device class | Class II |
| Regulation | 21 CFR 878.4810 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NUV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 234 |
| 2019 | 1 | 126 |
| 2021 | 1 | 56 |
| 2023 | 1 | 157 |
| 2026 | 1 | 107 |
Compare with all 510(k) review times · Search every NUV clearance
Top NUV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syneron Medical, Ltd. | 4 | 2012-09-13 |
| I-Tech Industries Srl | 2 | 2021-06-22 |
| Eleme Medical, Inc. | 2 | 2010-04-02 |
| Cutera, Inc. | 2 | 2009-10-01 |
| Zhengzhou PZ Laser Slim Technology Co., Ltd. | 1 | 2026-08-28 |
9 more applicants have NUV clearances. See the full list in Caduvo.
Most recent NUV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261582 | Zhengzhou PZ Laser Slim Technology Co., Ltd. | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) | 2026-08-28 | 107 |
| K231092 | B&M S.R.L. Marketing Nel Benessere | T-SHAPE 2 | 2023-09-22 | 157 |
| K211272 | I-Tech Industries Srl | ICOONE Laser Med (also referred to as ICOONE Medical laser) | 2021-06-22 | 56 |
| K182453 | I-Tech Industries Srl | ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) | 2019-01-11 | 126 |
| K161892 | Beijing Honkon Technologies Co., Ltd. | Slimming Treatment Device | 2017-03-02 | 234 |
Recalls for NUV devices
openFDA lists no recalls for product code NUV.
Frequently asked questions
What is FDA product code NUV?
NUV is the FDA product code for massager, vacuum, light induced heating. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel.
What device class is NUV?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code NUV?
Across 20 cleared submissions the average was 113 days from receipt to decision (median 110).
Which companies have the most NUV clearances?
Syneron Medical, Ltd. (4); I-Tech Industries Srl (2); Eleme Medical, Inc. (2); Cutera, Inc. (2); Zhengzhou PZ Laser Slim Technology Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NUV
- Run a recall and safety report across every NUV manufacturer
- Watch product code NUV 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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