510(k) · Cleared
ClearedSpectra 724
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 Nov 25, 1985 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Nov 25, 1985
- Review
- 13 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK854498 Spectra 724Daavlin Co. · 1985
- Descendant · cites it directly · 12 of its ownK050695 Flex Controlled Phototherapy EquipmentDaavlin Distributing Co. · 2005
- Descendant · 2 generations on · 6 of its ownK100378 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Daavlin Distributing Co. · 2010 · Recalled
- Descendant · 2 generations on · 4 of its ownK182215 ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company · 2018 · Recalled
- Descendant · 3 generations on · 2 of its ownK210881 M Series Phototherapy EquipmentDaavlin Distributing Co. · 2021 · Recalled
- Descendant · 4 generations on · 1 of its ownK230382 3 Series NeoLuxDaavlin Distributing Co. · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K050695Flex Controlled Phototherapy EquipmentDaavlin Distributing Co. · 2005 · cites it directly12descendants
- K1003781 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4Daavlin Distributing Co. · 2010 · 2 generations on6descendants
- K182215ClearLink Controlled Phototherapy EquipmentDaavlin Distributing Company · 2018 · 2 generations on4descendants
- K210881M Series Phototherapy EquipmentDaavlin Distributing Co. · 2021 · 3 generations on2descendants
- K2303823 Series NeoLuxDaavlin Distributing Co. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854498 | Spectra 724 | Daavlin Co. | 1985 | — |
| +1 | K050695 | Flex Controlled Phototherapy Equipment | Daavlin Distributing Co. | 2005 | — |
| +2 | K100378 | 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4 | Daavlin Distributing Co. | 2010 | 1 |
| +2 | K182215 | ClearLink Controlled Phototherapy Equipment | Daavlin Distributing Company | 2018 | 1 |
| +3 | K210881 | M Series Phototherapy Equipment | Daavlin Distributing Co. | 2021 | 1 |
| +4 | K230382 | 3 Series NeoLux | Daavlin Distributing Co. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 153 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K050695 (Daavlin Distributing Co., 2005) has gone furthest, with 12 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/K854498 · printed Nov 5, 2026
Cite this page
510(k) Report. “K854498: Spectra 724.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K854498
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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