FDA product code OHT: Light Based Over-The-Counter Hair Removal
OHT is the FDA product code for light based over-the-counter hair removal. It is a Class II device, regulated under 21 CFR 878.4810 and reviewed by the General and Plastic Surgery panel. FDA has cleared 164 510(k) submissions under OHT, 116 in the last five years, from 84 different applicants. The average 510(k) review took 92 days (median 84); 77 days on average over the last three years.
Definition
Over-the-counter device uses thermal energy to kill hair follicles for hair removal.
Classification
| Field | Value |
|---|---|
| Device name | Light Based Over-The-Counter Hair Removal |
| 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) |
510(k) clearances per year for OHT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 122 |
| 2018 | 8 | 116 |
| 2019 | 7 | 81 |
| 2020 | 1 | 28 |
| 2021 | 12 | 114 |
| 2022 | 25 | 83 |
| 2023 | 32 | 80 |
| 2024 | 26 | 75 |
| 2025 | 25 | 88 |
| 2026 | 8 | 69 |
Compare with all 510(k) review times · Search every OHT clearance
Top OHT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shenzhen Ulike Smart Electronics Co., Ltd. | 18 | 2026-05-21 |
| Cyden Limited | 15 | 2024-11-27 |
| El Global Trade, Ltd. | 6 | 2025-05-23 |
| Shenzhen Fansizhe Science and Technology Co., Ltd. | 5 | 2025-12-29 |
| Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. | 4 | 2024-06-18 |
79 more applicants have OHT clearances. See the full list in Caduvo.
Most recent OHT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262524 | ONE BEAUTY Technology Co., Ltd. | Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) | 2026-09-18 | 58 |
| K261705 | Shenzhen Jianchao Intelligent Technology Co., Ltd. | Hair Removal Device (R3C16-G Pro, R3C16-V Pro) | 2026-08-10 | 80 |
| K261325 | Shenzhen Ulike Smart Electronics Co., Ltd. | Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) | 2026-05-21 | 29 |
| K260594 | Shenzhen Xiazhifeng Electronic Co., Ltd. | IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM) | 2026-05-20 | 86 |
| K260742 | Shenzhen Ulike Smart Electronics Co., Ltd. | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) | 2026-05-05 | 60 |
Recalls for OHT devices
openFDA lists no recalls for product code OHT.
Frequently asked questions
What is FDA product code OHT?
OHT is the FDA product code for light based over-the-counter hair removal. 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 OHT?
Class II, regulation 21 CFR 878.4810. Typical premarket route: 510(k).
How long does a 510(k) take for product code OHT?
Across 164 cleared submissions the average was 92 days from receipt to decision (median 84).
Which companies have the most OHT clearances?
Shenzhen Ulike Smart Electronics Co., Ltd. (18); Cyden Limited (15); El Global Trade, Ltd. (6); Shenzhen Fansizhe Science and Technology Co., Ltd. (5); Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code OHT
- Run a recall and safety report across every OHT manufacturer
- Watch product code OHT 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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