510(k) · Cleared

Cleared

Xtrac XL, Model AL8000

K041943510(k) TraditionalCleared Oct 14, 200487-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

Photo Medex, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Oct 14, 2004 as substantially equivalent to K992914 (Acculase, Inc., 2000) and 4 other predicates after an 87-day review. Its family tree reaches back 4 generations to 1989. 11 later devices descend from it.

Decided: Oct 14, 2004
Review: 87 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 5

Its longest line of descent runs back 4 generations to K885026 (1989). 9 ancestors in all. 11 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK885026 Houva II UvbNational Biological Corp. · 1989
3 generations backK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
2 generations backK020847 Xtrac Excimer Laser System, Model AL7000Photo Medex, Inc. · 2002
1 generation backK031451 Xtracxl Plus Excimer Laser System, Model AL7000Photo Medex, Inc. · 2003
This deviceK041943 Xtrac XL, Model AL8000Photo Medex, Inc. · 2004
Descendant · cites it directly · 7 of its ownK073659 Xtrac Ultra 2, Model AL10000Photo Medex, Inc. · 2008
Descendant · 2 generations on · 3 of its ownK103540 Psoria-LightPsoria-Shield, Inc. · 2011
Descendant · cites it directly · 3 of its ownK062963 Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc · 2007 · Recalled
Descendant · 3 generations on · 2 of its ownK192411 Psoria-Shield AURORAPsoria-Shield · 2020
Descendant · 2 generations on · 2 of its ownK172639 PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2017

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2007high 3 (2020) · low 0 (2009)2026

Most influential descendants

Showing 5 of 11 · See all

K073659Xtrac Ultra 2, Model AL10000Photo Medex, Inc. · 2008 · cites it directly7descendants
K103540Psoria-LightPsoria-Shield, Inc. · 2011 · 2 generations on3descendants
K062963Pharos Excimer Laser System, Model EX-308Ra Medical Systems,Inc · 2007 · cites it directly3descendants
K192411Psoria-Shield AURORAPsoria-Shield · 2020 · 3 generations on2descendants
K172639PALLAS 308/311 Solid-State UV Laser SystemLaseroptek Co., Ltd. · 2017 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K885026	Houva II Uvb	National Biological Corp.	1989	—
−3	K992914	Excimer Laser Phototherapy System, AL7000	Acculase, Inc.	2000	—
−2	K020847	Xtrac Excimer Laser System, Model AL7000	Photo Medex, Inc.	2002	—
−1	K031451	Xtracxl Plus Excimer Laser System, Model AL7000	Photo Medex, Inc.	2003	—
0 (this device)	K041943	Xtrac XL, Model AL8000	Photo Medex, Inc.	2004	—
+1	K073659	Xtrac Ultra 2, Model AL10000	Photo Medex, Inc.	2008	—
+2	K103540	Psoria-Light	Psoria-Shield, Inc.	2011	—
+1	K062963	Pharos Excimer Laser System, Model EX-308	Ra Medical Systems,Inc	2007	2
+3	K192411	Psoria-Shield AURORA	Psoria-Shield	2020	—
+2	K172639	PALLAS 308/311 Solid-State UV Laser System	Laseroptek Co., Ltd.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	2	0
2001	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2011	1	0
2017	1	0
2018	1	0
2020	3	0
2023	2	0
2026	1	0

FIG. 1 — Lineage of K041943, 1989–2026Source: 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? (5)

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
*	K992914	Excimer Laser Phototherapy System, AL7000 Summary page 1 …em, Model AL8000 3. PREDICATE DEVICES Excimer Laser * Excimer Laser Phototherapy System, model AL7000, AccuLase (PhotoMedex), cleared via 5 10(k) K992914 * XTRAC Excimer Laser System. Model AL7000, PhotoMedex, Inc., cleared via 5 10(k) K003705 · XTRAC Exc…	Acculase, Inc.	2000	—
*	K003705	Xtrac Excimer Laser System, Model AL7000 Summary page 1 …AL7000, AccuLase (PhotoMedex), cleared via 5 10(k) K992914 * XTRAC Excimer Laser System. Model AL7000, PhotoMedex, Inc., cleared via 5 10(k) K003705 · XTRAC Excimer Laser System. Model AL7000, PhotoMedex, Inc., cleared via 510(k) K011382 * XTRAC Exci…	Photo Medex, Inc.	2001	—
*	K011382	Xtrac Excimer Laser System, Model AL 7000 Summary page 1 …Model AL7000, PhotoMedex, Inc., cleared via 5 10(k) K003705 · XTRAC Excimer Laser System. Model AL7000, PhotoMedex, Inc., cleared via 510(k) K011382 * XTRAC Excimer Laser System. Model AL7000, PhotoMedex, Inc., cleared via 5 10(k) K020847 * XTRAC XL…	Photo Medex, Inc.	2001	—
*	K020847	Xtrac Excimer Laser System, Model AL7000 Summary page 1 …Model AL7000, PhotoMedex, Inc., cleared via 510(k) K011382 * XTRAC Excimer Laser System. Model AL7000, PhotoMedex, Inc., cleared via 5 10(k) K020847 * XTRAC XL Plus Excimer Laser System. Model AL7000, PhotoMedex, Inc. cleared via 510(k) K031451…	Photo Medex, Inc.	2002	—
*	K031451	Xtracxl Plus Excimer Laser System, Model AL7000 Summary page 1 …L7000, PhotoMedex, Inc., cleared via 5 10(k) K020847 * XTRAC XL Plus Excimer Laser System. Model AL7000, PhotoMedex, Inc. cleared via 510(k) K031451 XIX-2 510(k) Sunlinar;. Mode AIt8…	Photo Medex, Inc.	2003	—

Also cleared against K992914: 6 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K073659	Xtrac Ultra 2, Model AL10000	Photo Medex, Inc.	2008	7
K062963	Pharos Excimer Laser System, Model EX-308	Ra Medical Systems,Inc	2007	3

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 15 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
None of the 9 ancestors has a recall.
Of its descendants, K073659 (Photo Medex, Inc., 2008) has gone furthest, with 7 descendants of its own.
6 other devices also cite its predicate K992914.

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?

UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041943 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041943: Xtrac XL, Model AL8000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041943

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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