510(k) · Cleared
ClearedEnvisu Spectral Domain Ophthalmic Imaging System (Sdois)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioptigen, Inc. · HLI Ophthalmoscope, Ac-Powered
Cleared on May 11, 2012 as substantially equivalent to K063343 (Bioptigen, Inc., 2006) after a 123-day review. Its family tree reaches back 4 generations to 2002. 6 later devices descend from it.
- Decided
- May 11, 2012
- Review
- 123 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K012727 (2002). 6 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 3 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 2 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 1 generation backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- This deviceK120057 Envisu Spectral Domain Ophthalmic Imaging System (Sdois)Bioptigen, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK241163 SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH · 2024
- Descendant · cites it directly · 1 of its ownK150722 EnFocus 2300, EnFocus 4400Bioptigen, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK142953 OCT-CameraOptomedical Technologies GmbH · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK253837 SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK200516 OCT-Camera ID 21101A3Optomedical Technologies GmbH · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH · 2024 · cites it directly1descendant
- K150722EnFocus 2300, EnFocus 4400Bioptigen, Inc. · 2015 · cites it directly1descendant
- K142953OCT-CameraOptomedical Technologies GmbH · 2015 · cites it directly1descendant
- K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH · 2026 · 2 generations on0descendants
- K200516OCT-Camera ID 21101A3Optomedical Technologies GmbH · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −3 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −2 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −1 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| 0 (this device) | K120057 | Envisu Spectral Domain Ophthalmic Imaging System (Sdois) | Bioptigen, Inc. | 2012 | — |
| +1 | K241163 | SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | 2024 | — |
| +1 | K150722 | EnFocus 2300, EnFocus 4400 | Bioptigen, Inc. | 2015 | — |
| +1 | K142953 | OCT-Camera | Optomedical Technologies GmbH | 2015 | 2 |
| +2 | K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | 2026 | — |
| +2 | K200516 | OCT-Camera ID 21101A3 | Optomedical Technologies GmbH | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging SystemSummary page 2…mography imaging technology and incoherent superluminiscent light emitting diode technology as the predicate S0015. The differences between the 2006 predicate, K063343, and the current subject SDOIS are the following design modifications incorporated to enhance device usability and performan… | 2006 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K241163 (Heidelberg Engineering GmbH, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K063343.
How does its category compare?
All HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
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…
Read the full statement (116 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120057 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120057: Envisu Spectral Domain Ophthalmic Imaging System (Sdois).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120057
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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