# DEN040009: Hamilton Thorne Zona Infrared Laser Optical System (Zilos TK)

- Pathway: De Novo (Post-NSE)
- Applicant: Hamilton Thorne Biosciences
- Decided: Nov 4, 2004 after 71 days
- Product code: MRX (System, Assisted Reproduction Laser)
- Device class: 2
- Regulation: 21 CFR 884.6200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K062256: HF54 Combination Ultrasound Interferential and Premodulated Stimulation System (2007), 2 descendants of its own
- K072256: HF54 Combination Ultrasound Interferential and Premodulated Stimulation System with Optional Hands-Free Operation, Model (2008), 1 descendant of its own
- K090250: Electro-Light Therapy (2010), 0 descendants of its own
- K062524: Octax Laser Shot System (2006), 0 descendants of its own

Source page: https://510kreport.com/device/DEN040009
Methodology: https://510kreport.com/methodology