Cogent Light Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Cogent Light Technologies, Inc.” (first 1994, latest 2000), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 63 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| FFS | Image, Illumination, Fiberoptic, For Endoscope | 2 | 2 |
| GCT | Light Source, Endoscope, Xenon Arc | 2 | 2 |
| FST | Light, Surgical, Fiberoptic | 1 | 1 |
Review panels
Most recent Cogent Light Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001698 | MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 | FFS | 2000-07-17 | 45 |
| K983714 | SOLARTEC SOURCE 270, MODEL # 90123 | FFS | 1998-12-23 | 63 |
| K971057 | COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM | GCT | 1997-03-28 | 4 |
| K936048 | LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) | FST | 1994-03-10 | 80 |
| K933405 | COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE | GCT | 1994-02-18 | 221 |
Recalls
openFDA lists no recalls under a recalling firm named Cogent Light Technologies, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cogent Diagnotics , Ltd. (31 510(k)s)
- Cogent Spine, LLC (3 510(k)s)
- Cogent (1 510(k)s)
- Cogent Therapeutics, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cogent Light Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Cogent Light Technologies, Inc.” (first 1994, latest 2000), across 3 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 Cogent Light Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cogent Light Technologies, Inc. is 63 days.
Which FDA product codes appear under Cogent Light Technologies, Inc.?
The most frequent FDA product codes under this applicant name are FFS (Image, Illumination, Fiberoptic, For Endoscope, 2); GCT (Light Source, Endoscope, Xenon Arc, 2); FST (Light, Surgical, Fiberoptic, 1).
Next steps
- See all 5 Cogent Light Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FFS, Cogent Light Technologies, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.