510(k) · Cleared

Cleared

Excimer Laser Phototherapy System, AL7000

K992914510(k) TraditionalCleared Jan 27, 2000150-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

Acculase, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jan 27, 2000 as substantially equivalent to K885026 (National Biological Corp., 1989) and 2 other predicates after a 150-day review. Its family tree reaches back 1 generation to 1989. 766 later devices descend from it.

Decided: Jan 27, 2000
Review: 150 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K885026 (1989). 3 ancestors in all. 766 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK885026 Houva II UvbNational Biological Corp. · 1989
This deviceK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
Descendant · cites it directly · 759 of its ownK020591 BclearLumenis · 2002
Descendant · cites it directly · 750 of its ownK021762 BclearLumenis, Inc. · 2002
Descendant · 2 generations on · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
Descendant · 3 generations on · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005

Showing 5 of 766 descendants. See all descendants

Descendants cleared per year

2002high 105 (2025) · low 3 (2003)2026

Most influential descendants

Showing 5 of 766 · See all

K020591BclearLumenis · 2002 · cites it directly759descendants
K021762BclearLumenis, Inc. · 2002 · cites it directly750descendants
K033946Lovely SystemMsq (M2), Ltd. · 2004 · 2 generations on737descendants
K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · 3 generations on402descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K885026	Houva II Uvb	National Biological Corp.	1989	—
0 (this device)	K992914	Excimer Laser Phototherapy System, AL7000	Acculase, Inc.	2000	—
+1	K020591	Bclear	Lumenis	2002	—
+1	K021762	Bclear	Lumenis, Inc.	2002	—
+2	K033946	Lovely System	Msq (M2), Ltd.	2004	—
+2	K042000	Modified MSQ Family of Lovely Light/Laser Systems	Msq (M2), Ltd.	2004	—
+3	K042630	Revlight Skin Care System	Skincare Technology, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	4	0
2003	3	0
2004	5	0
2005	4	0
2006	6	0
2007	16	0
2008	24	0
2009	14	0
2010	17	0
2011	18	0
2012	15	0
2013	24	0
2014	27	0
2015	26	0
2016	35	0
2017	35	0
2018	34	0
2019	23	0
2020	46	0
2021	37	0
2022	50	0
2023	49	0
2024	82	0
2025	105	0
2026	67	0

FIG. 1 — Lineage of K992914, 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

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What was it cleared against? (3)

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
*	K885026	Houva II Uvb Summary page 1 …ary name: Excimer Laser Phototherapy System, AL7000 PREDICATE DEVICES Ultraviolet Lamps e HOUVA II, Phototherapy Syslem National Biological Corporation 510(k) number: K885026 e UviSol, Phototherapy System National Biological Corporation, 510(k) number K934808 Excimer Laser e CVX-300 Excimer Laser Sys…	National Biological Corp.	1989	—
*	K934808	Uvisol and Uvisol II Summary page 1 …mps e HOUVA II, Phototherapy Syslem National Biological Corporation 510(k) number: K885026 e UviSol, Phototherapy System National Biological Corporation, 510(k) number K934808 Excimer Laser e CVX-300 Excimer Laser System Spectranetics Corp. ' PMA number: P910001 510 (k) Summary AL7000…	National Biological Corp.	1993	—
*	P910001	Spectranectics CVX-300 Excimer Laser System Summary page 1 …26 e UviSol, Phototherapy System National Biological Corporation, 510(k) number K934808 Excimer Laser e CVX-300 Excimer Laser System Spectranetics Corp. ' PMA number: P910001 510 (k) Summary AL7000 4. DEVICE DESCRIPTION The Excimer Laser Phototherapy System, AL7000 is a complete self-c…	Spectranetics Corp.	1993	—

Also cleared against K885026: 2 other devices →

What descends from it? (766)

See all 766

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

Number	Device	Applicant	Decided	Descendants
K020591	Bclear	Lumenis	2002	759
K021762	Bclear	Lumenis, Inc.	2002	750
K020847	Xtrac Excimer Laser System, Model AL7000	Photo Medex, Inc.	2002	295
K031451	Xtracxl Plus Excimer Laser System, Model AL7000	Photo Medex, Inc.	2003	12
K041943	Xtrac XL, Model AL8000	Photo Medex, Inc.	2004	11
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?

None of the 3 ancestors has a recall.
Of its descendants, K020591 (Lumenis, 2002) has gone furthest, with 759 descendants of its own.
2 other devices also cite its predicate K885026.

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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K992914 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992914: Excimer Laser Phototherapy System, AL7000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992914

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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