Lightlab Imaging, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Lightlab Imaging, Inc.” (first 2010, latest 2016), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 92 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 90 |
| 2014 | 2 | 78 |
| 2015 | 4 | 92 |
| 2016 | 1 | 91 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 8 | 8 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
Review panels
Most recent Lightlab Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160878 | OPTIS Metallic Stent Optimization E.4 SW | NQQ | 2016-06-29 | 91 |
| K152120 | OPTIS Mobile System | NQQ | 2015-10-29 | 91 |
| K151286 | OPTIS Integrated System Mobile Workstation | NQQ | 2015-08-05 | 83 |
| K150878 | ILUMIEN OPTIS | NQQ | 2015-07-15 | 105 |
| K150237 | ILUMIEN, Drageonfly OPTIS Imaging Catheter | NQQ | 2015-05-05 | 92 |
| K141453 | ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER | DQO | 2014-09-19 | 109 |
| K141769 | OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER | DQO | 2014-08-18 | 48 |
| K123369 | ILUMIEN OPTIS | NQQ | 2013-01-30 | 90 |
| K111201 | C7 XR IMAGING SYSTEM | NQQ | 2011-08-10 | 103 |
| K093857 | C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES | NQQ | 2010-04-30 | 135 |
Recalls
openFDA lists no recalls under a recalling firm named Lightlab Imaging, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Lightlab Imaging, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Lightlab Imaging, Inc.” (first 2010, latest 2016), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lightlab Imaging, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lightlab Imaging, Inc. is 92 days.
Which FDA product codes appear under Lightlab Imaging, Inc.?
The most frequent FDA product codes under this applicant name are NQQ (System, Imaging, Optical Coherence Tomography (Oct), 8); DQO (Catheter, Intravascular, Diagnostic, 2).
Next steps
- See all 10 Lightlab Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NQQ, Lightlab Imaging, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.