# ILY: Lamp, Infrared, Therapeutic Heating

- Device class: 2; regulation: 21 CFR 890.5500; FDA's rule: 510(k) exempt
- FDA decisions: 229
- 510(k) review time 2021–2025: median 249 days (middle half 126–280)
- Recalls: 13 (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)
- 2014: 11
- 2015: 11
- 2016: 8
- 2017: 5
- 2020: 1
- 2022: 2
- 2023: 1
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K032229: Quantum Warp 10 Light Delivery System (2003), cited by 15
- K001179: Super Nova, Acubeam (2000), cited by 13
- K040662: Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser Systems (2004), cited by 10
- K003538: TDP CQ-27 Heat Lamp (2001), cited by 10
- K043317: Omnilux Plus (2005), cited by 10
- K031612: Alt Laser, Model VTR 75 (2003), cited by 9
- K020017: Medx 1000 Series (2002), cited by 8
- K023621: Bioflex Professional Therapy System (2003), cited by 8
- K022888: Acubeam, Super Nova, Dio (2002), cited by 8
- K982546: Phaser-2000 (1998), cited by 7

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