# GEX: Powered Laser Surgical Instrument

- Device class: 2; regulation: 21 CFR 878.4810; FDA's rule: 510(k) required
- FDA decisions: 2,892
- 510(k) review time 2021–2025: median 95 days (middle half 67–193)
- Recalls: 85 (1 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: 67
- 2018: 51
- 2019: 41
- 2020: 52
- 2021: 53
- 2022: 60
- 2023: 52
- 2024: 82
- 2025: 83
- 2026: 57

## Most-cited predicates
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (2002), cited by 21
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL (2002), cited by 21
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), cited by 20
- K023954: Altus Medical Coolglide Laser Systems and Accessories (2003), cited by 19
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices (2001), cited by 19
- K030426: Omnilux Red (2003), cited by 19
- K030883: Omnilux Blue (2003), cited by 16
- K020021: Lyra Surgical Laser System and Accessiories (ND:Yag Configuration) (2002), cited by 15
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers (2003), cited by 15
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller (2002), cited by 15

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