# K120057: Envisu Spectral Domain Ophthalmic Imaging System (Sdois)

- Pathway: 510(k) (Traditional)
- Applicant: Bioptigen, Inc.
- Decided: May 11, 2012 after 123 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: 4 generations back to K012727 (2002). 4 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063343: Bioptigen Spectral Domain Ophthalmic Imaging System, Bioptigen, Inc. (2006) Summary page 2.

## Most influential descendants
- K241163: SPECTRALIS with Flex Module (2024), 1 descendant of its own
- K150722: EnFocus 2300, EnFocus 4400 (2015), 1 descendant of its own
- K142953: OCT-Camera (2015), 1 descendant of its own
- K253837: SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module (2026), 0 descendants of its own
- K200516: OCT-Camera ID 21101A3 (2020), 0 descendants of its own

## Indications for use
Bioptigen Envisu™ Spectral Domain Ophthalmic Imaging System (Envisu™ SDOIS) is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT). The Envisu™ SDOIS is indicated for use as an aid in the diagnosis of physiologic and pathologic conditions of the eye through non-contact optical imaging. Imaging of the various tissues of the eye is supported through the use of interchangeable lenses. It is indicated for use on patient populations from premature and neonatal infants to adult, and is suitable for patients ambulatory or confined. The system is indicated for use in upright or supine imaging, handheld or mounted, and is suited for imaging patients under anesthesia.

Source page: https://510kreport.com/device/K120057
Methodology: https://510kreport.com/methodology