510(k) · Cleared
ClearedProlite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction)
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 Dec 16, 2002 as substantially equivalent to K991935 (Esc Medical Systems, Ltd., 2000) after a 90-day review. Its family tree reaches back 5 generations to 1992. 23 later devices descend from it.
- Decided
- Dec 16, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K910422 (1992). 17 ancestors in all, the oldest K892514 (1990). 23 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 4 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 3 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 2 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 1 generation backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- This deviceK023081 Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair…Medical Bio Care Sweden AB · 2002
- Descendant · cites it directly · 11 of its ownK040659 Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc · 2004
- Descendant · cites it directly · 9 of its ownK032191 Omnilight Fluorescent Pulsed Light SystemLuxsano AB · 2003
- Descendant · 2 generations on · 8 of its ownK060234 Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc · 2006
- Descendant · 3 generations on · 6 of its ownK072331 Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008
- Descendant · 4 generations on · 4 of its ownK091664 GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K040659Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc · 2004 · cites it directly11descendants
- K032191Omnilight Fluorescent Pulsed Light SystemLuxsano AB · 2003 · cites it directly9descendants
- K060234Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc · 2006 · 2 generations on8descendants
- K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd. · 2008 · 3 generations on6descendants
- K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd. · 2009 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −4 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −3 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −2 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −1 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| 0 (this device) | K023081 | Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction) | Medical Bio Care Sweden AB | 2002 | — |
| +1 | K040659 | Mccue PLC Energist Ultra Variable Pulsed Light System | Mccue Plc | 2004 | — |
| +1 | K032191 | Omnilight Fluorescent Pulsed Light System | Luxsano AB | 2003 | — |
| +2 | K060234 | Mccue Energist Ultra VPL Intense Pulse Light System | Mccue Plc | 2006 | — |
| +3 | K072331 | Radiancy Mistral Device | Radiancy (Israel), Ltd. | 2008 | — |
| +4 | K091664 | GSD Intense Pulsed Light System, Models: GP666C4, GP666C | Shenzhen Gsd Tech Co., Ltd. | 2009 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K991935 | Epilight Hair Removal System, Photoderm HR SystemSummary page 1…79-GEX. 2 1 CFR 878-48 Legally Marketed Predicate Device: EpiLight / Photodm HR System K number K99 1935 Description of the ProLite / Plasmalite The ProLite / PlasmaliteMPX Pulsed Light System delivers MPX Pulsed Light System… | 2000 |
What descends from it? (23)
See all 233 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 10 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K040659 (Mccue Plc, 2004) has gone furthest, with 11 descendants of its own.
- 9 other devices also cite its predicate K991935.
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 ProLite / Plasmalite MPX is intended to be used for the
permanent reduction of unwanted hair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023081 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023081: Prolite / Plasmalite MPX Pulsed Light System (Permanent Hair Reduction).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023081
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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