Psoralite Corp.: FDA clearances and approvals
Psoralite Corp. has 5 FDA 510(k) clearances (first 1987, latest 1991), across 1 product code in 1 review panel. Median 510(k) review time: 82 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 |
Review panels
Most recent Psoralite Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K913760 | PSORALITE , PHOTOTHERAPY TREATMENT EQUIPMENT | FTC | 1991-10-28 | 67 |
| K890084 | PSORALITE PHOTOTHERAPY TREATMENT BOOTH, MDL 45000 | FTC | 1989-05-11 | 121 |
| K881385 | PSORALITE PHOTOTHERAPY TREATMENT BOOTH/PANEL | FTC | 1988-04-13 | 9 |
| K864511 | PSORALITE 18400 SERIES | FTC | 1987-02-04 | 82 |
| K864510 | PSORALITE 12800 SERIES | FTC | 1987-02-04 | 82 |
Recalls
openFDA lists no recalls under a recalling firm named Psoralite Corp..
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 Psoralite Corp. have?
Psoralite Corp. has 5 FDA 510(k) clearances (first 1987, latest 1991), across 1 product code in 1 review panel.
How long does FDA take to clear Psoralite Corp.'s 510(k)s?
The median time from FDA receipt to decision across Psoralite Corp.'s cleared 510(k)s is 82 days.
What devices does Psoralite Corp. make?
Its most frequent FDA product codes are FTC (Light, Ultraviolet, Dermatological, 5).
Has Psoralite Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Psoralite Corp. Related entities may recall under other names.
Next steps
- See all 5 Psoralite Corp. clearances with predicates and recalls
- Run predicate analysis for product code FTC, Psoralite Corp.'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.