510(k) · Cleared
ClearedSPR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiancy (Israel), Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Oct 24, 2003 as substantially equivalent to K030897 (Radiancy (Israel), Ltd., 2003) after a 23-day review. Its family tree reaches back 1 generation to 2003. 11 later devices descend from it.
- Decided
- Oct 24, 2003
- Review
- 23 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030897 (2003). 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK030897 SkinstationRadiancy (Israel), Ltd. · 2003
- This deviceK033181 SPR SystemRadiancy (Israel), Ltd. · 2003
- Descendant · cites it directly · 9 of its ownK041554 Aip Intense Pulsed Light SystemAesthera Corporation · 2005
- Descendant · 2 generations on · 4 of its ownK062048 Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006
- Descendant · 3 generations on · 3 of its ownK083730 IsolazAesthera Corporation · 2009
- Descendant · 2 generations on · 3 of its ownK062589 Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd. · 2006
- Descendant · 4 generations on · 1 of its ownK101415 TheraclearTheravant Corporation · 2010
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K041554Aip Intense Pulsed Light SystemAesthera Corporation · 2005 · cites it directly9descendants
- K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation · 2006 · 2 generations on4descendants
- K083730IsolazAesthera Corporation · 2009 · 3 generations on3descendants
- K062589Serenity PSF (Pneumatic Skin Flattening) SystemInolase 2002, Ltd. · 2006 · 2 generations on3descendants
- K101415TheraclearTheravant Corporation · 2010 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030897 | Skinstation | Radiancy (Israel), Ltd. | 2003 | — |
| 0 (this device) | K033181 | SPR System | Radiancy (Israel), Ltd. | 2003 | — |
| +1 | K041554 | Aip Intense Pulsed Light System | Aesthera Corporation | 2005 | — |
| +2 | K062048 | Aesthera Photopneumatic (PPX) System | Aesthera Corporation | 2006 | — |
| +3 | K083730 | Isolaz | Aesthera Corporation | 2009 | — |
| +2 | K062589 | Serenity PSF (Pneumatic Skin Flattening) System | Inolase 2002, Ltd. | 2006 | — |
| +4 | K101415 | Theraclear | Theravant Corporation | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 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 |
|---|---|---|---|
| * | K030897 | SkinstationSummary page 2…shment Registration Number: 9616256 Owner/operator number: 9040071 Predicate Devices Radiancy’s Skinstation0 System (K030897) Intended Use I Indications for Use The SPR is a pulsed light device intended for providing light therapy to the body and spec… | 2003 |
What descends from it? (11)
See all 112 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?
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 SPR is a pulsed light device intended for providing light therapy to the body and specifically indicated for treatment of pigmented and vascular lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033181: SPR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033181
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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