# OHT: Light Based Over-The-Counter Hair Removal

- Device class: 2; regulation: 21 CFR 878.4810; FDA's rule: 510(k) required
- FDA decisions: 167
- 510(k) review time 2021–2025: median 82 days (middle half 57–90)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 6
- 2018: 8
- 2019: 7
- 2020: 1
- 2021: 12
- 2022: 25
- 2023: 32
- 2024: 26
- 2025: 25
- 2026: 11

## Most-cited predicates
- K160968: iPulse SmoothSkin Gold Hair Removal Device (2016), cited by 27
- K192432: IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130 (2019), cited by 13
- K161428: PerfectSmooth (2017), cited by 10
- K181568: IPL Salon Hair Reduction System (2018), cited by 9
- K221002: IPL Hair Removal Device, Model (s): UI04A, UI04B, UI04C (2022), cited by 9
- K230122: IPL Hair Removal Device, Model (s): UI04 SD, UI04 DG (2023), cited by 8
- K173813: IPL Hair Removal Device Joy Version (2018), cited by 7
- K130315: Ipulse Hair Removal System (2013), cited by 7
- K103184: Silk'n Flash N GO (2010), cited by 7
- K190820: Aimanfun Lumea Comfort (2019), cited by 6

Source page: https://510kreport.com/product-code/OHT
Data by year (CSV): https://510kreport.com/product-code/OHT.csv