510(k) · Cleared

Cleared

Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair

K022568510(k) SpecialCleared Aug 29, 200227-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medical Bio Care Sweden AB · GEX Powered Laser Surgical Instrument

Cleared on Aug 29, 2002 as substantially equivalent to K013366 (Medical Bio Care Sweden AB, 2002) after a 27-day review. Its family tree reaches back 5 generations to 1992. 1,127 later devices descend from it.

Decided: Aug 29, 2002
Review: 27 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K910422 (1992). 12 ancestors in all, the oldest K892514 (1990). 1,127 later devices descend from it, 4 citing it directly.

By dateBy generation

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 backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
This deviceK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…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
Descendant · 2 generations on · 569 of its ownK032460 Profile BBL SystemSciton, Inc · 2003

Showing 5 of 1,127 descendants. See all descendants

Descendants cleared per year

2003high 130 (2025) · low 9 (2004)2026

Most influential descendants

Showing 5 of 1,127 · See all

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
K032460Profile BBL SystemSciton, Inc · 2003 · 2 generations on569descendants

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	K013366	Prolite Pulsed Light System for the Removal of Unwanted Hair	Medical Bio Care Sweden AB	2002	—
0 (this device)	K022568	Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair	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	—
+2	K032460	Profile BBL System	Sciton, Inc	2003	—

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	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	10	0
2004	9	0
2005	12	0
2006	19	0
2007	27	0
2008	41	0
2009	33	0
2010	28	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

FIG. 1 — Lineage of K022568, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K013366	Prolite Pulsed Light System for the Removal of Unwanted Hair Summary page 1 …79-GEX, 2 1 CFR 878-48 Legally Marketed Predicate Device: ProLite / Plasmalite MPX Pulsed Light System K number K 013366 Description of the ProLite / Plasmalite The ProLite / Plasmalite MPX Pulsed Light System delivers MPX Pulsed Light System…	Medical Bio Care Sweden AB	2002	—

Also cleared against K013366: 2 other devices →

What descends from it? (1,127)

See all 1,127

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023954	Altus Medical Coolglide Laser Systems and Accessories	Altus Medical, Inc.	2003	1,117
K040659	Mccue PLC Energist Ultra Variable Pulsed Light System	Mccue Plc	2004	11
K032191	Omnilight Fluorescent Pulsed Light System	Luxsano AB	2003	9
K024259	Pulsed Light Therapy System, Model# UV-300	New Star Lasers, Inc.	2003	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?

The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
None of the 12 ancestors has a recall.
Of its descendants, K023954 (Altus Medical, Inc., 2003) has gone furthest, with 1,117 descendants of its own.
2 other devices also cite its predicate K013366.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)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 Pulsed Light System is intended to remove unwanted

hair for all skin types according to the Fitzpatrick Scale.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022568 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022568: Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022568

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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