# K001527: Fotona Fidelis ER: Yag Laser System and Accesories

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.D.
- Decided: Jul 27, 2000 after 72 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
365 later devices descend from it; 4 cite it directly.
0 of 366 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012127: Pulsemaster Erbium Dental Laser System (2001), 241 descendants of its own
- K021508: Opusduo EC Dental Laser System (2002), 240 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own

Source page: https://510kreport.com/device/K001527
Methodology: https://510kreport.com/methodology