510(k) · Cleared
ClearedOmnilight Fluorescent Pulsed Light System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luxsano AB · GEX Powered Laser Surgical Instrument
Cleared on Aug 20, 2003 as substantially equivalent to K013365 (Medical Bio Care Sweden AB, 2002) and 3 other predicates after a 34-day review. Its family tree reaches back 6 generations to 1992. 9 later devices descend from it.
- Decided
- Aug 20, 2003
- Review
- 34 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K910422 (1992). 23 ancestors in all, the oldest K892514 (1990). 9 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 4 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 3 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 2 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 1 generation backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- This deviceK032191 Omnilight Fluorescent Pulsed Light SystemLuxsano AB · 2003
- Descendant · cites it directly · 3 of its ownK081219 Apollo Mini Ipl SystemSandstone Medical Technologies, LLC · 2008
- Descendant · cites it directly · 3 of its ownK073477 Photonova Family of Pulsed Light SystemsPhotonova Ofsweden AB · 2008
- Descendant · 2 generations on · 2 of its ownK110304 Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011
- Descendant · 2 generations on · 2 of its ownK092734 E-Light LineEspansione Marketing S.P.A · 2010
- Descendant · 3 generations on · 1 of its ownK124064 Young AgainEspansione Marketing S.P.A · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC · 2008 · cites it directly3descendants
- K073477Photonova Family of Pulsed Light SystemsPhotonova Ofsweden AB · 2008 · cites it directly3descendants
- K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC · 2011 · 2 generations on2descendants
- K092734E-Light LineEspansione Marketing S.P.A · 2010 · 2 generations on2descendants
- K124064Young AgainEspansione Marketing S.P.A · 2013 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −5 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −4 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −3 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −2 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −1 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| 0 (this device) | K032191 | Omnilight Fluorescent Pulsed Light System | Luxsano AB | 2003 | — |
| +1 | K081219 | Apollo Mini Ipl System | Sandstone Medical Technologies, LLC | 2008 | — |
| +1 | K073477 | Photonova Family of Pulsed Light Systems | Photonova Ofsweden AB | 2008 | — |
| +2 | K110304 | Apex ER. Yag / Ipl System | Sandstone Medical Technologies, LLC | 2011 | — |
| +2 | K092734 | E-Light Line | Espansione Marketing S.P.A | 2010 | — |
| +3 | K124064 | Young Again | Espansione Marketing S.P.A | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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? (4)
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 |
|---|---|---|---|
| * | K013365 | Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the Removal of…Summary page 1…GEX, 2 1 CFR 878-48 Legally Marketed Predicate Device: ProLite and Plasmalite M P X Pulsed Light System K number(s) 013365,022569,022568,02308l Description of the OmniLight Fluorescent The OmniLight Fluorescent Pulsed Light System delivers Pulsed L… | 2002 |
| * | K022569 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Vascular LesionsSummary page 1…1 CFR 878-48 Legally Marketed Predicate Device: ProLite and Plasmalite M P X Pulsed Light System K number(s) 013365,022569,022568,02308l Description of the OmniLight Fluorescent The OmniLight Fluorescent Pulsed Light System delivers Pulsed Light Sy… | 2002 |
| * | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted HairSummary page 1…78-48 Legally Marketed Predicate Device: ProLite and Plasmalite M P X Pulsed Light System K number(s) 013365,022569,022568,02308l Description of the OmniLight Fluorescent The OmniLight Fluorescent Pulsed Light System delivers Pulsed Light System… | 2002 |
| * | K023081 | Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction) | 2002 |
What descends from it? (9)
3 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?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K081219 (Sandstone Medical Technologies, LLC, 2008) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K013365.
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 OmniLight FPL System is intended to be used in the following procedures:
1. Hair Removal in all Skin types according to the Fitzpatrick Scale
2. Permanent Hair reduction
3. Treatment of Vascular Lesions
4. Treatment of Pigmented Lesion
5. Tattoo Removal
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032191: Omnilight Fluorescent 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/K032191
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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