# PDZ: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

- Device class: 2; regulation: 21 CFR 878.4810; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 90 days (middle half 80–330)
- 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)
- 2010: 1
- 2011: 4
- 2012: 6
- 2013: 1
- 2015: 1
- 2016: 1
- 2019: 1
- 2022: 2
- 2024: 1
- 2026: 1

## Most-cited predicates
- K093547: Pinpointe Footlaser (2010), cited by 12
- K103626: Cutera Genesisplus Laser System (2011), cited by 7
- K110375: Blueshine's Gold Series (2012), cited by 2
- K221363: AF Laser (2022), cited by 2
- K113702: Fotona XP ND: Yag Laser System (2012), cited by 2
- K150138: Aspen Laser Systems Therapy Laser System (2015), cited by 1
- K121508: Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-N (2012), cited by 1
- K113810: Modified Alma Lasers Harmony 1064NM (ND:Yag) Modules (2012), cited by 1
- K120938: The PL-1064 Laser System (2012), cited by 1
- K153164: LunulaLaser (2016), cited by 1

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