510(k) · Cleared
ClearedPhototherapeutix Model 2480AB
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 May 19, 1995 after a 549-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 19, 1995
- Review
- 549 days
- Class
- Class II
- Product code
- FTC
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK935525 Phototherapeutix Model 2480ABAvex Industries, Ltd. · 1995
- Descendant · cites it directly · 4 of its ownK993328 Surgilight, Inc Excimer LaserSurgilight, Inc. · 2000
- Descendant · 2 generations on · 3 of its ownK062963 Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc · 2007 · Recalled
- Descendant · 3 generations on · 2 of its ownK172639 PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2017
- Descendant · 4 generations on · 1 of its ownK191501 PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2020
- Descendant · 5 generations on · 0 of its ownK223588 PALLAS PremiumLaseroptek Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K993328Surgilight, Inc Excimer LaserSurgilight, Inc. · 2000 · cites it directly4descendants
- K062963Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc · 2007 · 2 generations on3descendants
- K172639PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2017 · 3 generations on2descendants
- K191501PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2020 · 4 generations on1descendant
- K223588PALLAS PremiumLaseroptek Co., Ltd. · 2023 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935525 | Phototherapeutix Model 2480AB | Avex Industries, Ltd. | 1995 | — |
| +1 | K993328 | Surgilight, Inc Excimer Laser | Surgilight, Inc. | 2000 | — |
| +2 | K062963 | Pharos Excimer Laser System, Model EX-308 | Ra Medical Systems,Inc | 2007 | 2 |
| +3 | K172639 | PALLAS 308/311 Solid-State UV Laser System | Laseroptek Co., Ltd. | 2017 | — |
| +4 | K191501 | PALLAS 308/311 Solid-State UV Laser System | Laseroptek Co., Ltd. | 2020 | — |
| +5 | K223588 | PALLAS Premium | Laseroptek Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993328 | Surgilight, Inc Excimer Laser | 2000 | 4 |
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, K993328 (Surgilight, Inc., 2000) has gone furthest, with 4 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/K935525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935525: Phototherapeutix Model 2480AB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935525
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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