# ONG: Powered Laser Surgical Instrument With MicrobeamFractional Output

- Device class: 2; regulation: 21 CFR 878.4810; FDA's rule: 510(k) required
- FDA decisions: 35
- 510(k) review time 2021–2025: median 148 days (middle half 93–202)
- Recalls: 3 (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)
- 2013: 3
- 2014: 2
- 2017: 1
- 2018: 2
- 2020: 1
- 2021: 1
- 2022: 3
- 2023: 1
- 2024: 1
- 2025: 4

## Most-cited predicates
- K130028: Resurfx 1565NM Laser Module (2013), cited by 4
- K090525: Loi System (2009), cited by 4
- K091420: Fraxel RE: Store Laser System, Model SR1500 (2009), cited by 3
- K110349: Clear+Brilliant Laser System (2011), cited by 3
- K101506: LUX1540, LUX1440 & LUX2940 Laser Handpieces (2010), cited by 3
- K100590: Edge CO2 Laser System (2010), cited by 2
- K100610: Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser Systems (2011), cited by 2
- K091446: Modification to LUX1540 Handpiece and Lux 1440 Handpiece (2009), cited by 2
- K101490: Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-US (2010), cited by 2
- K103664: Primus Aesthetic Platform (2011), cited by 2

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