510(k) · Cleared
ClearedProlite VL Pulsed Light System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Bio Care Sweden AB · GEX Powered Laser Surgical Instrument
Cleared on Jun 19, 2001 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1,122 later devices descend from it.
- Decided
- Jun 19, 2001
- Review
- 83 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
1,122 later devices descend from it, 2 citing it directly.
- This deviceK010928 Prolite VL Pulsed Light SystemMedical Bio Care Sweden AB · 2001
- Descendant · cites it directly · 1,121 of its ownK022569 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Vascular…Medical Bio Care Sweden AB · 2002
- Descendant · cites it directly · 1,117 of its ownK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- Descendant · 2 generations on · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
- Descendant · 2 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
- Descendant · 2 generations on · 654 of its ownK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
Showing 5 of 1,122 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,122 · See all- K022569Prolite/Plasmalite MPX Pulsed Light System for Treatment of Vascular LesionsMedical Bio Care Sweden AB · 2002 · cites it directly1,121descendants
- K023954Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003 · cites it directly1,117descendants
- K033946Lovely SystemMsq (M2), Ltd. · 2004 · 2 generations on737descendants
- K031671Polaris WRSyneron Medical, Ltd. · 2003 · 2 generations on678descendants
- K033172Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003 · 2 generations on654descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010928 | Prolite VL Pulsed Light System | Medical Bio Care Sweden AB | 2001 | — |
| +1 | K022569 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Vascular Lesions | Medical Bio Care Sweden AB | 2002 | — |
| +1 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| +2 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +2 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| +2 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 9 | 0 |
| 2004 | 8 | 0 |
| 2005 | 12 | 0 |
| 2006 | 17 | 0 |
| 2007 | 26 | 0 |
| 2008 | 41 | 0 |
| 2009 | 33 | 0 |
| 2010 | 27 | 0 |
| 2011 | 32 | 0 |
| 2012 | 28 | 0 |
| 2013 | 46 | 0 |
| 2014 | 46 | 0 |
| 2015 | 38 | 0 |
| 2016 | 56 | 0 |
| 2017 | 51 | 0 |
| 2018 | 46 | 0 |
| 2019 | 41 | 0 |
| 2020 | 56 | 0 |
| 2021 | 55 | 0 |
| 2022 | 77 | 0 |
| 2023 | 71 | 0 |
| 2024 | 98 | 0 |
| 2025 | 130 | 0 |
| 2026 | 77 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1,122)
See all 1,1222 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, K022569 (Medical Bio Care Sweden AB, 2002) has gone furthest, with 1,121 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 | — |
https://510kreport.com/device/K010928 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010928: Prolite VL Pulsed Light System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010928
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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