# K032099: Swiss Master Light

- Pathway: 510(k) (Traditional)
- Applicant: (Ems Sa) Electro Medical Systems
- Decided: Oct 27, 2003 after 111 days
- Product code: EBZ (Activator, Ultraviolet, For Polymerization)
- Device class: 2
- Regulation: 21 CFR 872.6070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K803209 (1981). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020091: Optilux 501, Kerr Corporation (Danbury) (2002) Summary page 1.
- K984247: Elipar Trilight, Espe Dental AG (1999) Summary page 1.

## Indications for use
The Swiss Master Light@ is a dental curing light that is designed for use in the photopolymerization of dental resins, activation of tooth whitening agents in bleaching procedures.

Source page: https://510kreport.com/device/K032099
Methodology: https://510kreport.com/methodology