Light Diagnostics: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Light Diagnostics” (first 1993, latest 1999), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 498 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 |
|---|---|---|---|
| GOE | Antisera, Fluorescent, Poliovirus 1-3 | 5 | 5 |
| GNM | Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 | 4 | 4 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| GNW | Antisera, Cf, Influenza Virus A, B, C | 1 | 1 |
| GNY | Antisera, Fluorescent, Adenovirus 1-33 | 1 | 1 |
| GOI | Antiserum, Fluorescent, Rabies Virus | 1 | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 | 1 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 | 1 |
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | 1 | 1 |
| GQX | Antiserum, Cf, Varicella-Zoster | 1 | 1 |
Plus 1 more product codes.
Review panels
- Microbiology (17)
- Immunology (2)
Most recent Light Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991880 | LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY | GQN | 1999-11-09 | 160 |
| K990141 | LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 | GQW | 1999-10-19 | 273 |
| K972975 | LIGHT DIAGNOSTICS RABIES DFA REAGENT | GOI | 1998-12-22 | 498 |
| K974302 | LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B | GNW | 1998-04-08 | 142 |
| K951821 | CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | LIN | 1996-06-07 | 414 |
| K951799 | VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | GQX | 1996-03-20 | 336 |
| K940034 | POLIOVIRUS 2 MONOCLONAL ANTIBODY | GOE | 1995-09-12 | 616 |
| K940026 | POLIOVIRUS BLEND MONOCLONAL ANTIBODIES | GOE | 1995-09-12 | 617 |
| K940017 | POLIOVIRUS 3 MONOCLONAL ANTIBODY | GOE | 1995-09-12 | 616 |
| K940363 | ENTEROVIRUS 70 MONCLONAL ANTIBODY | GOE | 1995-09-08 | 590 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Light Diagnostics.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Light Diagnostics (a text match, not an official crosswalk):
- G0008 — Administration of influenza virus vaccine (via GNW)
- Q2039 — Influenza virus vaccine, not otherwise specified (via GNW)
- Q2034 — Influenza virus vaccine, split virus, for intramuscular use (agriflu) (via GNW)
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.
- Light Tree Ventures Europe B.V. (13 510(k)s)
- Light Sources, Inc. (9 510(k)s)
- Light Age, Inc. (7 510(k)s)
- Light Bioscience, LLC (2 510(k)s)
- Light Force Therapy, Inc. (2 510(k)s)
- Light Instruments (2 510(k)s)
- Light Guide Optics International , Ltd. (1 510(k)s)
- Light Instrument, Ltd. (1 510(k)s)
- Light Relief, LLC (1 510(k)s)
- Light Technology Systems (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Light Diagnostics?
FDA lists 19 510(k) clearances under the applicant name “Light Diagnostics” (first 1993, latest 1999), across 11 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 Light Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Light Diagnostics is 498 days.
Which FDA product codes appear under Light Diagnostics?
The most frequent FDA product codes under this applicant name are GOE (Antisera, Fluorescent, Poliovirus 1-3, 5); GNM (Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6, 4); DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control, 2).
Next steps
- See all 19 Light Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code GOE, Light Diagnostics'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.