510(k) · Cleared

Cleared

Sharplan Epitouch Alexandrite Laser System (5000)

K971874510(k) TraditionalCleared Aug 18, 199790-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

Sharplan Lasers, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Aug 18, 1997 as substantially equivalent to K963094 (Cynosure, Inc., 1996) after a 90-day review. Its family tree reaches back 1 generation to 1996. 816 later devices descend from it.

Decided: Aug 18, 1997
Review: 90 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K963094 (1996). 816 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
This deviceK971874 Sharplan Epitouch Alexandrite Laser System (5000)Sharplan Lasers, Inc. · 1997
Descendant · cites it directly · 811 of its ownK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
Descendant · 2 generations on · 745 of its ownK991798 Acme Medical Aesthetic ND:Yag LaserAltus Medical · 2000
Descendant · 3 generations on · 739 of its ownK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
Descendant · 3 generations on · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
Descendant · 4 generations on · 656 of its ownK022923 Candela Gentle Yag Laser SystemCandela Corp. · 2003

Showing 5 of 816 descendants. See all descendants

Descendants cleared per year

1997high 85 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 816 · See all

K981351Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998 · cites it directly811descendants
K991798Acme Medical Aesthetic ND:Yag LaserAltus Medical · 2000 · 2 generations on745descendants
K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc. · 2002 · 3 generations on739descendants
K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · 3 generations on665descendants
K022923Candela Gentle Yag Laser SystemCandela Corp. · 2003 · 4 generations on656descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K963094	Cynosure Photogenica LP Dermatological Vascular Lesion Laser	Cynosure, Inc.	1996	—
0 (this device)	K971874	Sharplan Epitouch Alexandrite Laser System (5000)	Sharplan Lasers, Inc.	1997	—
+1	K981351	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	—
+2	K991798	Acme Medical Aesthetic ND:Yag Laser	Altus Medical	2000	—
+3	K014040	Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…	Altus Medical, Inc.	2002	—
+3	K022226	Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…	Altus Medical, Inc.	2002	—
+4	K022923	Candela Gentle Yag Laser System	Candela Corp.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	2	0
1999	3	0
2000	4	0
2002	8	0
2003	11	0
2004	10	0
2005	7	0
2006	9	0
2007	18	0
2008	28	0
2009	20	0
2010	19	0
2011	26	0
2012	23	0
2013	29	0
2014	33	0
2015	32	0
2016	42	0
2017	37	0
2018	35	0
2019	27	0
2020	44	0
2021	34	0
2022	60	0
2023	45	0
2024	75	0
2025	85	0
2026	49	0

FIG. 1 — Lineage of K971874, 1996–2026Source: 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? (1)

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
*	K963094	Cynosure Photogenica LP Dermatological Vascular Lesion Laser Summary page 1 …ty Assurance May 16, 1997 2. Model: Sharplan Model 5000 Alexandrite Laser System 3. Predicate Device: The Cynosure PhotoGenica LP Dermatological Vascular Lesion Laser (K963094) 4. Description: The Sharplan Model Alexandrite Laser System is a medical device which capable of emitting an invisible pulsed t…	Cynosure, Inc.	1996	—

Also cleared against K963094: 2 other devices →

What descends from it? (816)

See all 816

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

Number	Device	Applicant	Decided	Descendants
K981351	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	811
K973354	Sharplan Epitouch Alexandrite Laser System (5000)	Sharplan Lasers, Inc.	1997	222
K983977	Light Age Epicare Alexandrite Laser	Light Age, Inc.	1999	118
K042474	ARION	Wavelight Laser Technologie AG	2004	114
K032991	Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPX	Light Age, Inc.	2004	61
K090571	Alma Lasers ALEX755 Module	Alma Lasers, Ltd.	2009	58
K982316	Laseaway Alexandrite Laser System	Silver Creek, Inc.	1998	1

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?

Its one ancestor has no recall.
Of its descendants, K981351 (Candela Corp., 1998) has gone furthest, with 811 descendants of its own.
2 other devices also cite its predicate K963094.

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 Sharplan Model 5000 Alexandrite Surgical Laser System is intended for use in dermatology for the treatment of vascular lesions.

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/K971874 · printed Nov 4, 2026

Cite this page

510(k) Report. “K971874: Sharplan Epitouch Alexandrite Laser System (5000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971874

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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