# OAP: Laser, Comb, Hair

- Device class: 2; regulation: 21 CFR 890.5500; FDA's rule: 510(k) required
- FDA decisions: 115
- 510(k) review time 2021–2025: median 90 days (middle half 83–107)
- 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: 5
- 2018: 15
- 2019: 9
- 2020: 9
- 2021: 5
- 2022: 8
- 2023: 8
- 2024: 10
- 2025: 6
- 2026: 9

## Most-cited predicates
- K163170: Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 (2017), cited by 13
- K173729: Revian Red (2018), cited by 9
- K143199: Capillus 272 Pro (2015), cited by 8
- K122950: Laser Helmet (2013), cited by 8
- K160285: Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 (2016), cited by 8
- K162071: IllumiFlow Laser Cap (2017), cited by 7
- K142573: HairMax LaserComb, HairMax LaserComb (2014), cited by 7
- K140931: Igrow II Hair Growth System (2014), cited by 7
- K173678: Diode Laser Cap (2018), cited by 7
- K161875: LaserCap300, LaserCap224, LaserCap120, LaserCap80 (2016), cited by 6

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