510(k) · Cleared
ClearedBlu-U, Model 4170
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dusa Pharmaceuticals, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Sep 9, 2003 after a 90-day review. The FDA summary names its predicate without a number. 185 later devices descend from it.
- Decided
- Sep 9, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
185 later devices descend from it, 6 citing it directly.
- This deviceK031805 Blu-U, Model 4170Dusa Pharmaceuticals, Inc. · 2003
- Descendant · cites it directly · 139 of its ownK070185 Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red…Pharos Life Corporation · 2007
- Descendant · 2 generations on · 137 of its ownK080591 Tanda Skincare System, Model: PtscsPharos Life Corporation · 2008
- Descendant · 3 generations on · 125 of its ownK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- Descendant · 3 generations on · 81 of its ownK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
- Descendant · 3 generations on · 76 of its ownK124042 Tanda Mini Skincare SystemSyneron Beauty · 2013
Showing 5 of 185 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 185 · See all- K070185Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001Pharos Life Corporation · 2007 · cites it directly139descendants
- K080591Tanda Skincare System, Model: PtscsPharos Life Corporation · 2008 · 2 generations on137descendants
- K121435Silkn BlueHome Skinovations, Ltd. · 2013 · 3 generations on125descendants
- K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014 · 3 generations on81descendants
- K124042Tanda Mini Skincare SystemSyneron Beauty · 2013 · 3 generations on76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031805 | Blu-U, Model 4170 | Dusa Pharmaceuticals, Inc. | 2003 | — |
| +1 | K070185 | Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001 | Pharos Life Corporation | 2007 | — |
| +2 | K080591 | Tanda Skincare System, Model: Ptscs | Pharos Life Corporation | 2008 | — |
| +3 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| +3 | K131461 | Lightstim for Acne/ Lightstim for Acne Mini | Led Intellectual Properties, LLC | 2014 | — |
| +3 | K124042 | Tanda Mini Skincare System | Syneron Beauty | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 8 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 11 | 0 |
| 2022 | 11 | 0 |
| 2023 | 16 | 0 |
| 2024 | 17 | 0 |
| 2025 | 44 | 0 |
| 2026 | 22 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | ClearLight Phototherapy Device, Model CL-420 Named without a submission number |
What descends from it? (185)
See all 1856 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070185 | Tanda Skincare System, PLC-001, Tanda Blue, 414-001, Tanda Red, 660-001 | 2007 | 139 |
| K051259 | Versaclear Skin Therapy System, Model 100 | 2005 | 47 |
| K100378 | 1 Series Model 1 Series T2, 1 Series X2, 1 Series T4, 1 Series X4 | 2010 | 6 |
| K043575 | Dermillume, Model PRO1000 | 2005 | 4 |
| K062871 | Lumacare LC-122M Non-Coherent Light Source | 2006 | 1 |
| K100628 | Plasmaluxls | 2010 | 0 |
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, K070185 (Pharos Life Corporation, 2007) has gone furthest, with 139 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170 is intended to provide phototherapeutic light to the body. The BLU-U® is generally indicated to treat dermatological indications. The BLU-U® is specifically indicated to treat moderate inflammatory acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031805: Blu-U, Model 4170.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031805
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026