Light Sources, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Light Sources, Inc.” (first 1985, latest 2015), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 36 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 | 1 | 210 |
| 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 |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | 8 | 8 |
| LEJ | Booth, Sun Tan | 1 | 1 |
Review panels
Most recent Light Sources, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151370 | UV Lamps for Indoor Tanning Devices | LEJ | 2015-12-17 | 210 |
| K901324 | U.V. SUNLAMP 95UF-II | FTC | 1990-04-26 | 36 |
| K900649 | FLUORESCENT T12 UVA LAMP | FTC | 1990-03-28 | 47 |
| K900693 | U.V. SUNLAMP (U.V. LIGHT, DERMATOLOGIC) | FTC | 1990-03-27 | 42 |
| K883952 | U. V. SUNLAMP 95UF-11 | FTC | 1988-09-28 | 9 |
| K874889 | U.V. SUNLAMP 95 UF-11 | FTC | 1987-12-30 | 29 |
| K870167 | U.V. SUNLAMP 95UF-11 | FTC | 1987-02-09 | 26 |
| K854004 | FLUORESCENT T12 UVA TANNING LAMP | FTC | 1985-10-29 | 29 |
| K853545 | FLOURESCENT T12 UVA TANNING LAMP | FTC | 1985-10-01 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Light Sources, 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.
- Light Diagnostics (19 510(k)s)
- Light Tree Ventures Europe B.V. (13 510(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 Sources, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Light Sources, Inc.” (first 1985, latest 2015), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Light Sources, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Light Sources, Inc. is 36 days.
Which FDA product codes appear under Light Sources, Inc.?
The most frequent FDA product codes under this applicant name are FTC (Light, Ultraviolet, Dermatological, 8); LEJ (Booth, Sun Tan, 1).
Next steps
- See all 9 Light Sources, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTC, Light Sources, 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.