510(k) · Cleared
ClearedBioptigen Spectral Domain Ophthalmic Imaging System
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 Dec 13, 2006 as substantially equivalent to K033123 (Carl Zeiss Meditec, Inc., 2004) and 1 other predicate after a 37-day review. Its family tree reaches back 3 generations to 2002. 70 later devices descend from it.
- Decided
- Dec 13, 2006
- Review
- 37 days
- Class
- Class II
- Product code
- HLI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K012727 (2002). 70 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 2 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 1 generation backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- This deviceK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- Descendant · cites it directly · 64 of its ownK071250 CA, Model: CamOptovue, Inc. · 2007
- Descendant · 2 generations on · 58 of its ownK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 24 of its ownK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
- Descendant · 3 generations on · 17 of its ownK120238 Rtvue XR OctOptovue, Inc. · 2012
- Descendant · 4 generations on · 16 of its ownK153080 RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K071250CA, Model: CamOptovue, Inc. · 2007 · cites it directly64descendants
- K101505Rtvue Model Rtvue 100Optovue, Inc. · 2010 · 2 generations on58descendants
- K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc. · 2012 · 3 generations on24descendants
- K120238Rtvue XR OctOptovue, Inc. · 2012 · 3 generations on17descendants
- K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc. · 2016 · 4 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −2 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −1 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| 0 (this device) | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| +1 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| +2 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| +3 | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and… | Carl Zeiss Meditec, Inc. | 2012 | — |
| +3 | K120238 | Rtvue XR Oct | Optovue, Inc. | 2012 | — |
| +4 | K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (2)
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 |
|---|---|---|---|
| * | K033123 | Stratusoct with RNFL & Macula Normative DatabaseSummary page 1…evice Classification Name: Ophthalmoscope, A-C powered Regulation Number: 21 CFR 886.1570 Product Code: HLI Predicate Device: Carl Zeiss Meditec Stratus OCT (K033123), Carl Zeiss Humphrey OCT 3 (K012727) Intended Use: The Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acqui… | 2004 |
| * | K012727 | Humphrey OCT3Summary page 1…scope, A-C powered Regulation Number: 21 CFR 886.1570 Product Code: HLI Predicate Device: Carl Zeiss Meditec Stratus OCT (K033123), Carl Zeiss Humphrey OCT 3 (K012727) Intended Use: The Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acquire, process, display, and save depth-… | 2002 |
What descends from it? (70)
See all 702 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 4 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K071250 (Optovue, Inc., 2007) has gone furthest, with 64 descendants of its own.
- 3 other devices also cite its predicate K033123.
How does its category compare?
All HLI devicesHLI Ophthalmoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography. It is primarily intended for the imaging of retinal tissue, but the cornea, sciera, and conjunctiva can also be imaged by changing the focal position. Indications for use include the evaluation of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063343 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063343: Bioptigen Spectral Domain Ophthalmic Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063343
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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