# OLP: Over-The-Counter Powered Light Based Laser For Acne

- Device class: 2; regulation: 21 CFR 878.4810; FDA's rule: 510(k) required
- FDA decisions: 51
- 510(k) review time 2021–2025: median 245 days (middle half 86–263)
- Recalls: 4 (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)
- 2016: 6
- 2017: 4
- 2018: 5
- 2019: 2
- 2020: 1
- 2021: 6
- 2022: 5
- 2023: 3
- 2025: 3
- 2026: 1

## Most-cited predicates
- K081307: Omnilux Clear-U (2009), cited by 9
- K121435: Silkn Blue (2013), cited by 8
- K124042: Tanda Mini Skincare System (2013), cited by 7
- K214103: Shani Darden LED light therapy mask (2022), cited by 6
- K162098: LED Phototherapy Device (2017), cited by 5
- K180900: LED Light Therapy Device (2018), cited by 4
- K180847: Neutrogena Light Therapy Acne Mask+ (2018), cited by 4
- K142246: LightStim for Acne/ LightStim for Acne Mini (2015), cited by 4
- K160691: Acne Light Therapy Wand (2016), cited by 4
- K213184: MZ Skin LightMAX Supercharged LED Mask 2.0 (2021), cited by 4

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