510(k) · Cleared

Cleared

Palomar Spalight Pulsed Light System

K003886510(k) TraditionalCleared Mar 1, 200173-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. · GEX Powered Laser Surgical Instrument

Cleared on Mar 1, 2001 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 371 later devices descend from it.

Decided: Mar 1, 2001
Review: 73 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

371 later devices descend from it, 2 citing it directly.

This deviceK003886 Palomar Spalight Pulsed Light SystemPalomar Medical Technologies, Inc. · 2001
Descendant · cites it directly · 365 of its ownK041086 Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc. · 2005
Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
Descendant · 3 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
Descendant · 2 generations on · 166 of its ownK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
Descendant · 2 generations on · 157 of its ownK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010

Showing 5 of 371 descendants. See all descendants

Descendants cleared per year

2005high 42 (2025) · low 4 (2005)2026

Most influential descendants

Showing 5 of 371 · See all

K041086Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc. · 2005 · cites it directly365descendants
K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 2 generations on266descendants
K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 3 generations on198descendants
K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009 · 2 generations on166descendants
K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010 · 2 generations on157descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003886	Palomar Spalight Pulsed Light System	Palomar Medical Technologies, Inc.	2001	—
+1	K041086	Palomar Starlux Pulsed Light System	Palomar Medical Products, Inc.	2005	—
+2	K072564	Alma Lasers Harmony XL Multi-Application Platform	Alma Lasers, Ltd.	2008	—
+3	K083899	Revlite Q-Switched ND:Yag Laser System	Hoya Conbio, Inc.	2009	—
+2	K083889	Fotona QX ND:Yag/KTP Laser System Family	Fotona D.D.	2009	—
+2	K100270	Artisan Aesthetic System	Palomar Medical Technologies, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	4	0
2006	5	0
2007	4	0
2008	7	0
2009	7	0
2010	8	0
2011	10	0
2012	7	0
2013	6	0
2014	16	0
2015	15	0
2016	23	0
2017	21	0
2018	20	0
2019	12	0
2020	26	0
2021	21	0
2022	32	0
2023	26	0
2024	34	0
2025	42	0
2026	25	0

FIG. 1 — Lineage of K003886, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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? (371)

See all 371

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

Number	Device	Applicant	Decided	Descendants
K041086	Palomar Starlux Pulsed Light System	Palomar Medical Products, Inc.	2005	365
K041554	Aip Intense Pulsed Light System	Aesthera Corporation	2005	9

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, K041086 (Palomar Medical Products, Inc., 2005) has gone furthest, with 365 descendants of its own.

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	—

https://510kreport.com/device/K003886 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003886: Palomar Spalight 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/K003886

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026