# K150722: EnFocus 2300, EnFocus 4400

- Pathway: 510(k) (Traditional)
- Applicant: Bioptigen, Inc.
- Decided: Dec 2, 2015 after 257 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K012727 (2002). 5 ancestors in all.
1 later device descends from it; 1 cites 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)
- K120057: Envisu Spectral Domain Ophthalmic Imaging System (Sdois), Bioptigen, Inc. (2012) Summary page 4.

## Most influential descendants
- K162783: EnFocus 2300, EnFocus 4400 (2016), 0 descendants of its own

## Indications for use
The Bioptigen EnFocusTM device is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT). The EnFocusTM is indicated for use as an aid in the visualization of physiologic and pathologic conditions of the eye through non-contact optical imaging. It is indicated for use on patient populations from premature and neonatal infants to adult. The system is indicated for use in supine imaging, mounted to a surgical microscope, with cooperative patients or patients under anesthesia.

Source page: https://510kreport.com/device/K150722
Methodology: https://510kreport.com/methodology