510(k) · Cleared
ClearedPsoralite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Daavlin Co. · FTC Light, Ultraviolet, Dermatological
Cleared on Aug 26, 1993 after a 189-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 760 later devices descend from it.
- Decided
- Aug 26, 1993
- Review
- 189 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 0
760 later devices descend from it, 1 citing it directly.
- This deviceK930856 PsoraliteDaavlin Co. · 1993
- Descendant · cites it directly · 759 of its ownK020591 BclearLumenis · 2002
- Descendant · 2 generations on · 750 of its ownK021762 BclearLumenis, Inc. · 2002
- Descendant · 2 generations on · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
- Descendant · 3 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · 3 generations on · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
Showing 5 of 760 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 760 · See all- K020591BclearLumenis · 2002 · cites it directly759descendants
- K021762BclearLumenis, Inc. · 2002 · 2 generations on750descendants
- K033946Lovely SystemMsq (M2), Ltd. · 2004 · 2 generations on737descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 3 generations on517descendants
- K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · 3 generations on402descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930856 | Psoralite | Daavlin Co. | 1993 | — |
| +1 | K020591 | Bclear | Lumenis | 2002 | — |
| +2 | K021762 | Bclear | Lumenis, Inc. | 2002 | — |
| +2 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +3 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +3 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 16 | 0 |
| 2008 | 23 | 0 |
| 2009 | 14 | 0 |
| 2010 | 17 | 0 |
| 2011 | 18 | 0 |
| 2012 | 15 | 0 |
| 2013 | 24 | 0 |
| 2014 | 27 | 0 |
| 2015 | 26 | 0 |
| 2016 | 35 | 0 |
| 2017 | 35 | 0 |
| 2018 | 33 | 0 |
| 2019 | 23 | 0 |
| 2020 | 45 | 0 |
| 2021 | 37 | 0 |
| 2022 | 50 | 0 |
| 2023 | 49 | 0 |
| 2024 | 82 | 0 |
| 2025 | 105 | 0 |
| 2026 | 67 | 0 |
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? (760)
See all 7601 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020591 | Bclear | 2002 | 759 |
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.
What does this lineage say?
- Of its descendants, K020591 (Lumenis, 2002) has gone furthest, with 759 descendants of its own.
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/K930856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930856: Psoralite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930856
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026