# K101691: Lifelines Photic Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Lifelines, Ltd.
- Decided: Aug 10, 2010 after 55 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: 3 generations back to K003154 (2001). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053606: BE Plus / Aura-LTM64 Amplifier, Eb Neuro S.P.A. (2006) Summary page 1.

## Most influential descendants
- K251366: EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) (2025), 0 descendants of its own
- K211974: LED PHOTIC System (2021), 0 descendants of its own
- K173936: Natus Photic Stimulator (2018), 0 descendants of its own

## Indications for use
The Lifelines Photic Stimulator is indicated for photic activation of the EEG during an EEG study and in the generation of visual evoked potentials.

Source page: https://510kreport.com/device/K101691
Methodology: https://510kreport.com/methodology