# FSY: Light, Surgical, Ceiling Mounted

- Device class: 2; regulation: 21 CFR 878.4580; FDA's rule: 510(k) exempt
- FDA decisions: 74
- Recalls: 265 (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)
- 2003: 4
- 2004: 4
- 2006: 3
- 2007: 3
- 2008: 2
- 2009: 2
- 2010: 5
- 2012: 2
- 2013: 3
- 2014: 7

## Most-cited predicates
- K070442: Powerled Surgical Light System (2007), cited by 7
- K061317: ILED (2006), cited by 7
- K072072: Harmony Led-1 Surgical Lighting System (2007), cited by 5
- K965130: Chromophare (1997), cited by 4
- K083066: Chromophare E 778 and E 558 (2008), cited by 3
- K093009: Mach Led SC (2010), cited by 3
- K024132: Chromophare X 65 (2003), cited by 3
- K982063: Alm Prismalix (PRX) Surgical Light (1998), cited by 2
- K042395: Outpatient Iii Minor Surgery Light (2004), cited by 2
- K031068: Stryker Visum Surgical Lighting System (2003), cited by 2

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