510(k) · Cleared

Cleared

Modification to Epi-Star Surgical Laser System, M0DEL DS-60

K013864510(k) TraditionalCleared Feb 8, 200279-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

Nidek, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Feb 8, 2002 as substantially equivalent to K990119 (Nidek, Inc., 2000) after a 79-day review. Its family tree reaches back 5 generations to 1996. 49 later devices descend from it.

Decided: Feb 8, 2002
Review: 79 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K963094 (1996). 9 ancestors in all. 49 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
4 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
3 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
2 generations backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
1 generation backK990119 Epi-Star Surgical Laser SysterNidek, Inc. · 2000
This deviceK013864 Modification to Epi-Star Surgical Laser System, M0DEL DS-60Nidek, Inc. · 2002
Descendant · cites it directly · 48 of its ownK040727 CRYO 5Zimmer Elektromedizin GmbH · 2004
Descendant · 2 generations on · 36 of its ownK060407 Juniper Cooling DeviceJuniper Medical Technology, Inc. · 2006
Descendant · 3 generations on · 35 of its ownK063715 Juniper Cooling Device XtraJuniper Medical, Inc. · 2007
Descendant · 3 generations on · 34 of its ownK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
Descendant · 4 generations on · 33 of its ownK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2004high 6 (2022) · low 0 (2005)2026

Most influential descendants

Showing 5 of 49 · See all

K040727CRYO 5Zimmer Elektromedizin GmbH · 2004 · cites it directly48descendants
K060407Juniper Cooling DeviceJuniper Medical Technology, Inc. · 2006 · 2 generations on36descendants
K063715Juniper Cooling Device XtraJuniper Medical, Inc. · 2007 · 3 generations on35descendants
K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007 · 3 generations on34descendants
K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008 · 4 generations on33descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K963094	Cynosure Photogenica LP Dermatological Vascular Lesion Laser	Cynosure, Inc.	1996	—
−4	K972767	Candela Gentlelase GL Dermatological Vascular Lesion Laser	Candela Corp.	1997	1
−3	K974381	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	—
−2	K981351	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	—
−1	K990119	Epi-Star Surgical Laser Syster	Nidek, Inc.	2000	—
0 (this device)	K013864	Modification to Epi-Star Surgical Laser System, M0DEL DS-60	Nidek, Inc.	2002	—
+1	K040727	CRYO 5	Zimmer Elektromedizin GmbH	2004	—
+2	K060407	Juniper Cooling Device	Juniper Medical Technology, Inc.	2006	—
+3	K063715	Juniper Cooling Device Xtra	Juniper Medical, Inc.	2007	—
+3	K072152	Juniper CLN1 Dermal Cooling Device	Juniper Medical, Inc.	2007	—
+4	K080118	Zeltiq Aesthetics CLN1 Dermal Cooling Device	Zeltiq Aesthetics	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	3	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	3	0
2007	2	0
2008	2	0
2009	3	0
2012	1	0
2014	1	0
2015	4	0
2016	3	0
2017	4	0
2018	1	0
2019	3	0
2020	2	0
2021	2	0
2022	6	0
2023	3	0
2024	5	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K013864, 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
*	K990119	Epi-Star Surgical Laser Syster Summary page 1 …me: Surgical Laser Instrument 21 CFR 878.4810 78 GEX IDENTIFICATION OF PREDICATE DEVICES Company - Device 510(k) No. Date Cleared Nidek, Inc, Epi-Star Surgical Laser K990119 07/27/2000 System DEVICE DESCRIPTION The Epi-Star Surgical Laser System is an 800 nm continuous wave device coupled with cool…	Nidek, Inc.	2000	—

What descends from it? (49)

See all 49

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040727	CRYO 5	Zimmer Elektromedizin GmbH	2004	48

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 6 years and passes through 3 companies; a new generation was cleared every 12 months on median.
1 of the 9 ancestors has a recall of any class.
Of its descendants, K040727 (Zimmer Elektromedizin GmbH, 2004) has gone furthest, with 48 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.

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 Epi-Star Surgical Laser System is intended to be used for Plastic Surgery and Dermatology, with the intended uses for the treatment of vascular and pigmented lesions and for the removal of hair in skin types I — VL

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/K013864 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013864: Modification to Epi-Star Surgical Laser System, M0DEL DS-60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013864

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026