510(k) · Cleared

Cleared

Smoothlase Alexandrite Laser System

K990043510(k) TraditionalCleared Feb 11, 199936-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

Leisegang Medical, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Feb 11, 1999 as substantially equivalent to K971737 (Cynosure, Inc., 1997) and 1 other predicate after a 36-day review. Its family tree reaches back 4 generations to 1996.

Decided: Feb 11, 1999
Review: 36 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K963094 (1996). 10 ancestors in all, the oldest K944090 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
3 generations backK971874 Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc. · 1997
2 generations backK973354 Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc. · 1997
1 generation backK982316 Laseaway Alexandrite Laser SystemSilver Creek, Inc. · 1998
This deviceK990043 Smoothlase Alexandrite Laser SystemLeisegang Medical, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K963094	Cynosure Photogenica LP Dermatological Vascular Lesion Laser	Cynosure, Inc.	1996	—
−3	K971874	Sharplan Epitouch Alexandrite Laser System (5000)	Sharplan Lasers, Inc.	1997	—
−2	K973354	Sharplan Epitouch Alexandrite Laser System (5000)	Sharplan Lasers, Inc.	1997	—
−1	K982316	Laseaway Alexandrite Laser System	Silver Creek, Inc.	1998	—
0 (this device)	K990043	Smoothlase Alexandrite Laser System	Leisegang Medical, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
1995	1	0
1996	2	0
1997	1	0

FIG. 1 — Lineage of K990043, 1996–1999Source: 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? (2)

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
*	K971737	Cynosure Photogenica Lpir Dermatological Laser Summary page 1 …Alexandrite Laser System is substantially equivalent to numerous devices that are currently commercially available. These devices include the Cynosure PhotoGenica LPIR (K971737) and the Lambda LaseAway Alexandrite Laser distributed by Silver Creek Surgical (K982316). The SmoothLASE ™ Alexandrite Laser Sy…	Cynosure, Inc.	1997	—
*	K982316	Laseaway Alexandrite Laser System Summary page 1 …tly commercially available. These devices include the Cynosure PhotoGenica LPIR (K971737) and the Lambda LaseAway Alexandrite Laser distributed by Silver Creek Surgical (K982316). The SmoothLASE ™ Alexandrite Laser System is safe and effective for the intended purpose of removal of unwanted body hair on a…	Silver Creek, Inc.	1998	—

Also cleared against K971737: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 3 years and passes through 4 companies; a new generation was cleared every 8 months on median.
None of the 10 ancestors has a recall.
7 other devices also cite its predicate K971737.

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?

The SmoothLASE Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The SmoothLASE Alexandrite Laser System is intended for use only by qualified physicians trained in the safe operation of the system.

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/K990043 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990043: Smoothlase Alexandrite Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990043

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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