510(k) · Cleared
Recalled · Class II · 2021OCT-Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optomedical Technologies GmbH · HLI Ophthalmoscope, Ac-Powered
Cleared on Mar 4, 2015 as substantially equivalent to K120057 (Bioptigen, Inc., 2012) after a 145-day review. Its family tree reaches back 5 generations to 2002. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 4, 2015
- Review
- 145 days
- Class
- Class II
- Product code
- HLI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K012727 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 4 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 3 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 2 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 1 generation backK120057 Envisu Spectral Domain Ophthalmic Imaging System (Sdois)Bioptigen, Inc. · 2012
- This deviceK142953 OCT-CameraOptomedical Technologies GmbH · 2015
- Descendant · cites it directly · 0 of its ownK200516 OCT-Camera ID 21101A3Optomedical Technologies GmbH · 2020
Most influential descendants
Showing 1 of 1 · See all- K200516OCT-Camera ID 21101A3Optomedical Technologies GmbH · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −4 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −3 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −2 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −1 | K120057 | Envisu Spectral Domain Ophthalmic Imaging System (Sdois) | Bioptigen, Inc. | 2012 | — |
| 0 (this device) | K142953 | OCT-Camera | Optomedical Technologies GmbH | 2015 | — |
| +1 | K200516 | OCT-Camera ID 21101A3 | Optomedical Technologies GmbH | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HLI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K120057 | Envisu Spectral Domain Ophthalmic Imaging System (Sdois)Summary page 5…raditional 510(k) Premarket Submission OCT‐Camera 5. Predicate Device Device trade name: Envisu™ SDOIS Manufacturer name: Bioptigen Inc. 510(k) number: K120057 6. Device Description The OCT‐Camera can be attached to the camera port of surgical microscopes. The OCT‐Camera is completely i… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200516 | OCT-Camera ID 21101A3 | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2021 | Class II | Z-0477-2022 | Software design (manufacturing process) | 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 | Software design (manufacturing process) | Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is safely switched off |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K200516 (Optomedical Technologies GmbH, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K120057.
How does its category compare?
All HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HLI
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · HLI
112in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HLI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HLI
2in 2024
MAUDE reports naming product code HLI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | 36 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 4 | 112 | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 2 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (116 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142953: OCT-Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142953
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026