Ultralite: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ultralite” (first 1977, latest 1991), across 4 product codes in 2 review panels. 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 | 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 | 3 | 3 |
| IOB | Lamp, Infrared, Non Heating | 1 | 1 |
| KGL | Cabinet, Phototherapy (Puva) | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Ultralite 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910091 | ULTRALITE PANELITE | IOB | 1991-05-30 | 141 |
| K861963 | ULTRALITE HF1236 HAND AND FOOT SYSTEM | FTC | 1986-06-25 | 36 |
| K820492 | SPECTRA305 | FTC | 1982-03-31 | 36 |
| K827123 | SPECTRA (ULTRAVIOLET PRODUCTS) | — | 1982-03-05 | 31 |
| K820280 | SPECTRA 305/350 | KGL | 1982-03-05 | 31 |
| K761179 | PSORALITE | FTC | 1977-05-03 | 152 |
Recalls
openFDA lists no recalls under a recalling firm named Ultralite.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ultralite?
FDA lists 6 510(k) clearances under the applicant name “Ultralite” (first 1977, latest 1991), across 4 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 Ultralite?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ultralite is 36 days.
Which FDA product codes appear under Ultralite?
The most frequent FDA product codes under this applicant name are FTC (Light, Ultraviolet, Dermatological, 3); IOB (Lamp, Infrared, Non Heating, 1); KGL (Cabinet, Phototherapy (Puva), 1).
Next steps
- See all 6 Ultralite clearances with predicates and recalls
- Run predicate analysis for product code FTC, Ultralite'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.