510(k) · Cleared

Cleared

Erbium Fractional Handpiece

K071768510(k) TraditionalCleared Nov 5, 2007129-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 Products, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Nov 5, 2007 after a 129-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 162 later devices descend from it.

Decided: Nov 5, 2007
Review: 129 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

162 later devices descend from it, 5 citing it directly.

This deviceK071768 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2007
Descendant · cites it directly · 159 of its ownK073583 Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc. · 2008
Descendant · 2 generations on · 158 of its ownK091446 Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc. · 2009
Descendant · cites it directly · 158 of its ownK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
Descendant · cites it directly · 157 of its ownK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
Descendant · cites it directly · 156 of its ownK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010

Showing 5 of 162 descendants. See all descendants

Descendants cleared per year

2008high 22 (2025) · low 1 (2012)2026

Most influential descendants

Showing 5 of 162 · See all

K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc. · 2008 · cites it directly159descendants
K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc. · 2009 · 2 generations on158descendants
K083900Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009 · cites it directly158descendants
K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010 · cites it directly157descendants
K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010 · cites it directly156descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K071768	Erbium Fractional Handpiece	Palomar Medical Products, Inc.	2007	—
+1	K073583	Modification to Palomar LUX1540 Handpiece	Palomar Medical Products, Inc.	2008	—
+2	K091446	Modification to LUX1540 Handpiece and Lux 1440 Handpiece	Palomar Medical Products, Inc.	2009	—
+1	K083900	Erbium Fractional Handpiece	Palomar Medical Products, Inc.	2009	—
+1	K100270	Artisan Aesthetic System	Palomar Medical Technologies, Inc.	2010	—
+1	K101506	LUX1540, LUX1440 & LUX2940 Laser Handpieces	Palomar Medical Technologies, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2009	2	0
2010	2	0
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 K071768, 2007–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (162)

See all 162

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

Number	Device	Applicant	Decided	Descendants
K073583	Modification to Palomar LUX1540 Handpiece	Palomar Medical Products, Inc.	2008	159
K083900	Erbium Fractional Handpiece	Palomar Medical Products, Inc.	2009	158
K100270	Artisan Aesthetic System	Palomar Medical Technologies, Inc.	2010	157
K101506	LUX1540, LUX1440 & LUX2940 Laser Handpieces	Palomar Medical Technologies, Inc.	2010	156
K073158	Sculpture 2.94 ER:Yag System	Hoya Conbio, Inc.	2008	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?

Of its descendants, K073583 (Palomar Medical Products, Inc., 2008) has gone furthest, with 159 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. 2007, this device’s year, is highlighted.

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?

Dermatological procedures requiring the coagulation of soft tissue;

Skin resurfacing procedures.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K071768 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071768: Erbium Fractional Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071768

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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