# K142953: OCT-Camera

- Pathway: 510(k) (Traditional)
- Applicant: Optomedical Technologies GmbH
- Decided: Mar 4, 2015 after 145 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: 2 (0 Class I)
- 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 5.

## Most influential descendants
- K200516: OCT-Camera ID 21101A3 (2020), 0 descendants of its own

## Recalls of this device
- Nov 3, 2021 · Class II · Z-0477-2022: Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off
- Nov 3, 2021 · Class II · Z-0478-2022: Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off

## Indications for use
OptoMedical Technologies OCT-Camera is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SD-OCT). The OCT-Camera is indicated for the 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 supine imaging, mounted to a surgical microscope HS Hi-R NEO 900A NIR (Haag-Streit), and is suited for imaging patients under anesthesia.

Source page: https://510kreport.com/device/K142953
Methodology: https://510kreport.com/methodology