Philips Lighting Co.: FDA clearances and approvals
Philips Lighting Co. has 6 FDA 510(k) clearances (first 1991, latest 2002), across 2 product codes in 1 review panel. Median 510(k) review time: 58 days.
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 |
|---|---|---|---|
| FTC | Light, Ultraviolet, Dermatological | 5 | 5 |
| LEJ | Booth, Sun Tan | 1 | 1 |
Review panels
Most recent Philips Lighting Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021514 | PHILIPS PLS9W/12/2P UVB | FTC | 2002-05-16 | 7 |
| K021092 | PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B | FTC | 2002-05-16 | 42 |
| K940672 | CLEO TL80W PROFESSIONAL CLEO TL80W PROFESSIONAL R, CLEO TL100 W PROFESSIONAL | LEJ | 1994-03-18 | 30 |
| K935840 | TL 20W/12/RS & TL 40W/12/RS | FTC | 1994-02-24 | 79 |
| K922963 | TL100W/12 | FTC | 1992-09-02 | 75 |
| K910767 | TL100W/01 UVB LAMP | FTC | 1991-05-23 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Philips Lighting Co..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Philips Lighting Co. have?
Philips Lighting Co. has 6 FDA 510(k) clearances (first 1991, latest 2002), across 2 product codes in 1 review panel.
How long does FDA take to clear Philips Lighting Co.'s 510(k)s?
The median time from FDA receipt to decision across Philips Lighting Co.'s cleared 510(k)s is 58 days.
What devices does Philips Lighting Co. make?
Its most frequent FDA product codes are FTC (Light, Ultraviolet, Dermatological, 5); LEJ (Booth, Sun Tan, 1).
Has Philips Lighting Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Philips Lighting Co. Related entities may recall under other names.
Next steps
- See all 6 Philips Lighting Co. clearances with predicates and recalls
- Run predicate analysis for product code FTC, Philips Lighting Co.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.