510(k) · Cleared

Cleared

LUX1540, LUX1440 & LUX2940 Laser Handpieces

K101506510(k) TraditionalCleared Sep 1, 201092-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

Palomar Medical Technologies, Inc. · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output

Cleared on Sep 1, 2010 as substantially equivalent to K100270 (Palomar Medical Technologies, Inc., 2010) and 9 other predicates after a 92-day review. Its family tree reaches back 15 generations to 1992. 156 later devices descend from it.

Decided: Sep 1, 2010
Review: 92 days
Class: Class II
Product code: ONG
Recalls: None
Predicates: 10

Its longest line of descent runs back 15 generations to K910422 (1992). 220 ancestors in all, the oldest K820106 (1982). 156 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 15 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
11 generations between
3 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
2 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
1 generation backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
This deviceK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
Descendant · cites it directly · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Descendant · 2 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Descendant · 3 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
Descendant · 2 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
Descendant · cites it directly · 57 of its ownK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011

Show all 15 generations

Root · 15 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
14 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
13 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
12 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
11 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
10 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
9 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
8 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
7 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
6 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
5 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
4 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
3 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
2 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
1 generation backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
This deviceK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010

Showing 5 of 156 descendants. See all descendants

Descendants cleared per year

2011high 22 (2025) · low 1 (2012)2026

Most influential descendants

Showing 5 of 156 · See all

K101916Joule Multi-Platform SystemSciton, Inc · 2011 · cites it directly111descendants
K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 2 generations on70descendants
K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 3 generations on62descendants
K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · 2 generations on57descendants
K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011 · cites it directly57descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−15	K910422	Model RD-1200 Ruby Laser System	Spectrum Medical Technologies, Inc.	1992	—
−14	K961279	Sharplan Lasers, Inc. Ruby Laser System	Sharplan Lasers, Inc.	1996	—
−13	K962446	Sharplan Ruby Laser System	Sharplan Lasers, Inc.	1997	—
−12	K974536	Photoderm HR System	Esc Medical Systems, Ltd.	1998	—
−11	K991935	Epilight Hair Removal System, Photoderm HR System	Esc Medical Systems, Ltd.	2000	—
−10	K014040	Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…	Altus Medical, Inc.	2002	—
−9	K023193	Candela Gentle Yag Laser System	Candela Corp.	2002	—
−8	K033172	Candela Gentleyag Family of Laser Systems	Candela Corp.	2003	—
−7	K040617	Reliant Laser System II	Reliant Technologies, Inc.	2004	—
−6	K060310	Fraxel II SR Laser System and Accessories	Reliant Technologies, Inc.	2006	—
−5	K062303	Fraxel II SR Laser System	Reliant Technologies, Inc.	2007	—
−4	K070284	Fralex SR 1500 Laser System (Fralex II SR Laser System)	Reliant Technologies, Inc.	2007	—
−3	K080244	Palomar Lux 1540 Handpiece	Palomar Medical Products, Inc.	2008	—
−2	K083900	Erbium Fractional Handpiece	Palomar Medical Products, Inc.	2009	—
−1	K100270	Artisan Aesthetic System	Palomar Medical Technologies, Inc.	2010	—
0 (this device)	K101506	LUX1540, LUX1440 & LUX2940 Laser Handpieces	Palomar Medical Technologies, Inc.	2010	—
+1	K101916	Joule Multi-Platform System	Sciton, Inc	2011	—
+2	K132806	Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece	Fotona D.D.	2014	—
+3	K143723	SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro	Fotona D.D.	2015	—
+2	K140009	Soprano Ice Multi-Application & Multi-Technology Platform	Alma Lasers, Ltd.	2014	—
+1	K110907	Palomar Icon (TM) Aesthetic System	Palomar Medical Technologies, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	2	0
1986	1	0
1988	2	0
1989	1	0
1990	2	0
1991	5	0
1993	8	0
1994	13	0
1995	11	0
1996	13	0
1997	14	0
1998	12	0
1999	9	0
2000	16	0
2001	21	0
2002	25	0
2003	20	0
2004	12	0
2005	4	0
2006	2	0
2007	6	0
2008	4	0
2009	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	4	0
2012	1	0
2013	1	0
2014	4	0
2015	6	0
2016	6	0
2017	7	0
2018	10	0
2019	6	0
2020	16	0
2021	10	0
2022	20	0
2023	13	0
2024	18	0
2025	22	0
2026	12	0

FIG. 1 — Lineage of K101506, 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 ONG? 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 ONG device

#1 K250402 AVAVA™ Skin Treatment Systemscore 19.1 · 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? (10)

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
*	K100270	Artisan Aesthetic System Summary page 1 …(21 CFR § 878.4810) PRODUCT CODE: GEX, ONG 3. PREDICATE DEVCE Palomar Erbium Handpiece (Lux2940 Handpiece) K100270, K083900, K071768, K071152, K063571 Palomar Medical Technologies, Inc. Lux 1540 Handpiece K100270,…	Palomar Medical Technologies, Inc.	2010	—
*	K083900	Erbium Fractional Handpiece Summary page 1 …(21 CFR § 878.4810) PRODUCT CODE: GEX, ONG 3. PREDICATE DEVCE Palomar Erbium Handpiece (Lux2940 Handpiece) K100270, K083900, K071768, K071152, K063571 Palomar Medical Technologies, Inc. Lux 1540 Handpiece K100270, K090195,…	Palomar Medical Products, Inc.	2009	—
*	K071768	Erbium Fractional Handpiece Summary page 1 …FR § 878.4810) PRODUCT CODE: GEX, ONG 3. PREDICATE DEVCE Palomar Erbium Handpiece (Lux2940 Handpiece) K100270, K083900, K071768, K071152, K063571 Palomar Medical Technologies, Inc. Lux 1540 Handpiece K100270, K090195, K091446,…	Palomar Medical Products, Inc.	2007	—
*	K071152	Palomar Erbium Handpiece Summary page 1 …4810) PRODUCT CODE: GEX, ONG 3. PREDICATE DEVCE Palomar Erbium Handpiece (Lux2940 Handpiece) K100270, K083900, K071768, K071152, K063571 Palomar Medical Technologies, Inc. Lux 1540 Handpiece K100270, K090195, K091446, K080244,…	Palomar Medical Products, Inc.	2007	—
*	K063571	Palomar LUX2940 Handpiece Summary page 1 …PRODUCT CODE: GEX, ONG 3. PREDICATE DEVCE Palomar Erbium Handpiece (Lux2940 Handpiece) K100270, K083900, K071768, K071152, K063571 Palomar Medical Technologies, Inc. Lux 1540 Handpiece K100270, K090195, K091446, K080244, K060301…	Palomar Medical Technologies, Inc.	2007	—
*	K090195	Palomar LUX1540 Handpiece Summary page 1 …e (Lux2940 Handpiece) K100270, K083900, K071768, K071152, K063571 Palomar Medical Technologies, Inc. Lux 1540 Handpiece K100270, K090195, K091446, K080244, K060301 Palomar Medical Technologies, Inc. Lux 1440 Handpiece K100270, K073583,…	Palomar Medical Technologies, Inc.	2009	—
*	K091446	Modification to LUX1540 Handpiece and Lux 1440 Handpiece Summary page 1 …0 Handpiece) K100270, K083900, K071768, K071152, K063571 Palomar Medical Technologies, Inc. Lux 1540 Handpiece K100270, K090195, K091446, K080244, K060301 Palomar Medical Technologies, Inc. Lux 1440 Handpiece K100270, K073583, K091446…	Palomar Medical Products, Inc.	2009	—
*	K080244	Palomar Lux 1540 Handpiece Summary page 1 …ce) K100270, K083900, K071768, K071152, K063571 Palomar Medical Technologies, Inc. Lux 1540 Handpiece K100270, K090195, K091446, K080244, K060301 Palomar Medical Technologies, Inc. Lux 1440 Handpiece K100270, K073583, K091446 510(k)…	Palomar Medical Products, Inc.	2008	—
*	K060301	Palomar LUX1540 Handpiece Summary page 1 …K100270, K083900, K071768, K071152, K063571 Palomar Medical Technologies, Inc. Lux 1540 Handpiece K100270, K090195, K091446, K080244, K060301 Palomar Medical Technologies, Inc. Lux 1440 Handpiece K100270, K073583, K091446 510(k) Summary…	Palomar Medical Technologies, Inc.	2006	—
*	K073583	Modification to Palomar LUX1540 Handpiece Summary page 1 …Lux 1540 Handpiece K100270, K090195, K091446, K080244, K060301 Palomar Medical Technologies, Inc. Lux 1440 Handpiece K100270, K073583, K091446 510(k) Summary Page 1 of 2 LuxlS 4O, Luxl1440 & Lux2940 H…	Palomar Medical Products, Inc.	2008	—

Also cleared against K100270: 4 other devices →

What descends from it? (156)

See all 156

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

Number	Device	Applicant	Decided	Descendants
K101916	Joule Multi-Platform System	Sciton, Inc	2011	111
K110907	Palomar Icon (TM) Aesthetic System	Palomar Medical Technologies, Inc.	2011	57
K103664	Primus Aesthetic Platform	Palomar Medical Technologies, Inc.	2011	7

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 18 years and passes through 8 companies; a new generation was cleared every 10 months on median.
7 of the 220 ancestors have a recall of any class.
Of its descendants, K101916 (Sciton, Inc, 2011) has gone furthest, with 111 descendants of its own.
4 other devices also cite its predicate K100270.

How does its category compare?

All ONG devices

ONG Powered Laser Surgical Instrument With MicrobeamFractional Output: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · ONG

4in 2025

2007high 6 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ONG

97in 2025

2007high 243 (2013) · low 97 (2025)2026

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

Recalls per year · ONG

2in 2024

2007high 2 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ONG

1in 2025

2007high 40 (2017) · low 0 (2007)2025

MAUDE reports naming product code ONG, 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	0	—	0	0
2008	0	—	0	0
2009	4	160	0	0
2010	4	176	1	3
2011	6	122	0	2
2012	2	—	0	4
2013	3	243	0	4
2014	2	—	0	6
2015	0	—	0	8
2016	0	—	0	8
2017	1	—	0	40
2018	2	—	0	27
2019	0	—	0	15
2020	1	—	0	3
2021	1	—	0	9
2022	3	203	0	2
2023	1	—	0	3
2024	1	—	2	11
2025	4	97	0	1
2026	0	—	0	—

What is it indicated for?

The Lux1540 and Lux2940 fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.

The Lux 1440 and Lux:2940 fractional combined treatment is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregulariiies, dyschromia and pigmented lesions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101506 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101506: LUX1540, LUX1440 & LUX2940 Laser Handpieces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101506

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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