OHTClass II
Light Based Over-The-Counter Hair Removal
21 CFR 878.4810 / General, Plastic Surgery
OHT is the FDA product code for Light Based Over-The-Counter Hair Removal, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "Over-the-counter device uses thermal energy to kill hair follicles for hair removal". As of , FDA records hold 163 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- OHT
- Device name
- Light Based Over-The-Counter Hair Removal
- FDA definition
- Over-the-counter device uses thermal energy to kill hair follicles for hair removal.
- Regulation
- 21 CFR 878.4810
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 165
- Ingested recalls
- 0
Clearances, product code OHT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 3 |
| 2017 | 6 |
| 2018 | 8 |
| 2019 | 7 |
| 2020 | 1 |
| 2021 | 12 |
| 2022 | 25 |
| 2023 | 32 |
| 2024 | 26 |
| 2025 | 25 |
| 2026 | 9 |
Applicants with the most clearances
Product code OHT| Applicant | Clearances |
|---|---|
| Shenzhen Ulike Smart Electronics Co.,Ltd | 18 |
| Cyden Limited | 13 |
| El Global Trade Ltd. | 6 |
| Shenzhen Fansizhe Science and Technology Co., Ltd. | 5 |
| Home Skinovations, Ltd. | 4 |
| Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. | 4 |
| Shenzhen Mlay Intelligent Technology Co., Ltd. | 4 |
| Shenzhen Jianchao Intelligent Technology Co., Ltd. | 3 |
| Shenzhen Qianyu Technology Co., Ltd. | 3 |
| Shenzhen Qiaochengli Technology Co., Ltd | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Alovea Healthcare Co., Ltd.
- Beijing Beautemax Technology Limited
- Beijing Perfectlaser Technology Co.,Ltd
- Beijing Spiritlaser Science & Technology Co., Ltd.
- Beijing Winkonlaser Technology Limited
- Bestway Plastic and Metal Products Ltd.
- Conair LLC.
- Cyden Limited
- CYDEN Ltd
- Cyden Medical Technology (Zhejiang) Co., Ltd
- DC Altfeld - Procter & Gamble
- Dongguan Boyuan Intelligent Technology Co., Ltd
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
