510(k) · Cleared
ClearedPhototherapeutix Model 1650B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avex Industries, Ltd. · FTC Light, Ultraviolet, Dermatological
Cleared on Feb 21, 1995 after a 558-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
- Decided
- Feb 21, 1995
- Review
- 558 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FTC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTC device
- #1 K242977 308nm Excimer Phototherapy Device (CN-308E…score 14.8 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FTC devicesFTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTC
76in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTC
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTC
8in 2025
MAUDE reports naming product code FTC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 53 | 0 | 0 |
| 2008 | 3 | 41 | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 5 | 125 | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 3 | 98 | 0 | 8 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 3 | 88 | 0 | 0 |
| 2019 | 2 | — | 0 | 14 |
| 2020 | 5 | 237 | 0 | 4 |
| 2021 | 3 | 89 | 0 | 48 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 4 | 48 | 0 | 5 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 3 | 76 | 1 | 8 |
| 2026 | 4 | 91 | 3 | — |
https://510kreport.com/device/K933953 · printed Nov 4, 2026
Cite this page
510(k) Report. “K933953: Phototherapeutix Model 1650B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933953
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026