# K211974: LED PHOTIC System

- Pathway: 510(k) (Traditional)
- Applicant: Micromed S.P.A.
- Decided: Sep 23, 2021 after 90 days
- Product code: GWE (Stimulator, Photic, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003154 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101691: Lifelines Photic Stimulator, Lifelines, Ltd. (2010) Summary page 4.

## Indications for use
LED PHOTIC System is an accessory indicated for photic activation of brain during the electroencephalographic (EEG) studies. It always has to be used in combination with an EEG system, in order to evaluate particular anomalies of the brain activity due to the intermittent photic stimulation. The product must be used only by qualified personnel (physicians or technicians of neurophysiopathology) for the execution of EEG exams in a professional environment.

Source page: https://510kreport.com/device/K211974
Methodology: https://510kreport.com/methodology