# K043367: Glaid Ocular Electrophysiology Device

- Pathway: 510(k) (Traditional)
- Applicant: Lace Electronica S.R.L.
- Decided: Nov 17, 2005 after 344 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Electro-Diagnostic Imaging, Inc. VERIS System: named in the summary without a submission number
- (no number) Doran Instruments Inc. Maculoscope: named in the summary without a submission number
- (no number) LKC Technologies Inc. Electroretinograph: named in the summary without a submission number

## Most influential descendants
- K081591: Neucodia (2009), 1 descendant of its own
- K101763: Diopsys Nova Vep Vision Testing System (2011), 0 descendants of its own

## Indications for use
The GLAID device is indicated for use in the measurement of visual electrophysiologic potentials, including the electroretinogram (ERG), pattern electroretinogram (PERG), visual evoked potential (VEP) and electrooculogram (EOG), as an aid in the diagnosis and management of Glaucoma when used in conjunction with other established methods of diagnosis and disease management

Source page: https://510kreport.com/device/K043367
Methodology: https://510kreport.com/methodology