510(k) · Cleared

Cleared

Palomar SLP 1000

K010580510(k) TraditionalCleared May 22, 200184-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 May 22, 2001 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 175 later devices descend from it.

Decided: May 22, 2001
Review: 84 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

175 later devices descend from it, 4 citing it directly.

This deviceK010580 Palomar SLP 1000Palomar Medical Technologies, Inc. · 2001
Descendant · cites it directly · 174 of its ownK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
Descendant · cites it directly · 173 of its ownK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
Descendant · cites it directly · 172 of its ownK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
Descendant · 2 generations on · 171 of its ownK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
Descendant · cites it directly · 169 of its ownK053527 Spectra Hair Removal LaserSpectragenics, Inc. · 2008

Showing 5 of 175 descendants. See all descendants

Descendants cleared per year

2001high 30 (2023) · low 0 (2002)2026

Most influential descendants

Showing 5 of 175 · See all

K011747Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001 · cites it directly174descendants
K032846Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003 · cites it directly173descendants
K052848Spectra Hair Removal LaserSpectragenics, Inc. · 2005 · cites it directly172descendants
K060839Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006 · 2 generations on171descendants
K053527Spectra Hair Removal LaserSpectragenics, Inc. · 2008 · cites it directly169descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010580	Palomar SLP 1000	Palomar Medical Technologies, Inc.	2001	—
+1	K011747	Palomar LC 100 Diode Laser	Palomar Medical Technologies, Inc.	2001	—
+1	K032846	Spectra Pulsed Diode Laser, Model DR-1	Spectragenics, Inc.	2003	—
+1	K052848	Spectra Hair Removal Laser	Spectragenics, Inc.	2005	—
+2	K060839	Abc Hair Removal System	Palomar Medical Technologies, Inc.	2006	—
+1	K053527	Spectra Hair Removal Laser	Spectragenics, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0
2005	1	0
2006	1	0
2008	3	0
2009	1	0
2010	1	0
2011	1	0
2012	4	0
2013	5	0
2014	8	0
2015	4	0
2016	3	0
2017	5	0
2018	9	0
2019	6	0
2020	2	0
2021	15	0
2022	24	0
2023	30	0
2024	22	0
2025	18	0
2026	10	0

FIG. 1 — Lineage of K010580, 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? (175)

See all 175

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

Number	Device	Applicant	Decided	Descendants
K011747	Palomar LC 100 Diode Laser	Palomar Medical Technologies, Inc.	2001	174
K032846	Spectra Pulsed Diode Laser, Model DR-1	Spectragenics, Inc.	2003	173
K052848	Spectra Hair Removal Laser	Spectragenics, Inc.	2005	172
K053527	Spectra Hair Removal Laser	Spectragenics, Inc.	2008	169

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, K011747 (Palomar Medical Technologies, Inc., 2001) has gone furthest, with 174 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/K010580 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010580: Palomar SLP 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010580

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