FDA product code NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
NFO is the FDA product code for stimulator, transcutaneous electrical, aesthetic purposes. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel. FDA has cleared 82 510(k) submissions under NFO, 38 in the last five years, from 62 different applicants. The average 510(k) review took 208 days (median 170); 138 days on average over the last three years. FDA has posted 2 recalls for NFO devices.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Device class | Class II |
| Regulation | 21 CFR 882.5890 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NFO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 7 | 228 |
| 2018 | 5 | 185 |
| 2019 | 3 | 154 |
| 2020 | 2 | 276 |
| 2021 | 7 | 237 |
| 2022 | 2 | 106 |
| 2023 | 8 | 217 |
| 2024 | 5 | 130 |
| 2025 | 16 | 132 |
| 2026 | 7 | 153 |
Compare with all 510(k) review times · Search every NFO clearance
Top NFO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carol Cole Company Dba Nuface | 6 | 2021-02-24 |
| Xtreem Pulse, LLC | 4 | 2026-09-11 |
| Micro Current Technology, Inc. | 4 | 2025-07-18 |
| Carol Cole Company | 4 | 2014-04-17 |
| Ya-Man, Ltd. | 3 | 2025-10-29 |
57 more applicants have NFO clearances. See the full list in Caduvo.
Most recent NFO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261370 | Guangdong Newdermo Biotech Co., Ltd. | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | 2026-09-16 | 142 |
| K262861 | Xtreem Pulse, LLC | PureLift Pro Max | 2026-09-11 | 29 |
| K260387 | Hironic Co., Ltd. | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) | 2026-08-31 | 206 |
| K253932 | Shenzhen Kaiyan Medical Equipment Co., Ltd. | FACEGYM Pro Device (HD-109) | 2026-07-23 | 226 |
| K260179 | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | VITA Multi-Function Head Brush (TB-2343F, TB-2442F) | 2026-06-03 | 133 |
Recalls for NFO devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-01-06.
Frequently asked questions
What is FDA product code NFO?
NFO is the FDA product code for stimulator, transcutaneous electrical, aesthetic purposes. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel.
What device class is NFO?
Class II, regulation 21 CFR 882.5890. Typical premarket route: 510(k).
How long does a 510(k) take for product code NFO?
Across 82 cleared submissions the average was 208 days from receipt to decision (median 170).
Which companies have the most NFO clearances?
Carol Cole Company Dba Nuface (6); Xtreem Pulse, LLC (4); Micro Current Technology, Inc. (4); Carol Cole Company (4); Ya-Man, Ltd. (3).
Have NFO devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2012-01-06.
Next steps
- Run an FDA pathway report with predicate devices for product code NFO
- Run a recall and safety report across every NFO manufacturer
- Watch product code NFO 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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