510(k) · Cleared

Cleared

Coherent Slimline Single Lumen Aspiration Needle Kit

K960413510(k) TraditionalCleared Apr 4, 199666-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

Lumenis, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Apr 4, 1996 as substantially equivalent to K923575 (Coherent Medical Group, 1993) and 2 other predicates after a 66-day review. Its family tree reaches back 1 generation to 1990. 483 later devices descend from it.

Decided: Apr 4, 1996
Review: 66 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K902990 (1990). 3 ancestors in all. 483 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK902990 Coherent Holmium:Yag Surgical LaserCoherent Medical Division · 1990
This deviceK960413 Coherent Slimline Single Lumen Aspiration Needle KitLumenis, Inc. · 1996
Descendant · cites it directly · 351 of its ownK980685 Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag LasersLumenis, Inc. · 1998
Descendant · cites it directly · 350 of its ownK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
Descendant · 2 generations on · 342 of its ownK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
Descendant · cites it directly · 225 of its ownK050738 FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · Recalled
Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006

Showing 5 of 483 descendants. See all descendants

Descendants cleared per year

1998high 42 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 483 · See all

K980685Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag LasersLumenis, Inc. · 1998 · cites it directly351descendants
K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…Lumenis, Inc. · 1999 · cites it directly350descendants
K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)…Lumenis · 2001 · 2 generations on342descendants
K050738FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · cites it directly225descendants
K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K902990	Coherent Holmium:Yag Surgical Laser	Coherent Medical Division	1990	—
0 (this device)	K960413	Coherent Slimline Single Lumen Aspiration Needle Kit	Lumenis, Inc.	1996	—
+1	K980685	Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag Lasers	Lumenis, Inc.	1998	—
+1	K990947	Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO…	Lumenis, Inc.	1999	—
+2	K011703	Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…	Lumenis	2001	2
+1	K050738	FT Fiber Optic Delivery Systems	Fibertech GmbH	2005	5
+2	K060033	Profile Multi-Platform System	Sciton, Inc	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1993	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	1	0
2001	2	0
2002	8	0
2003	3	0
2004	3	0
2005	5	0
2006	4	0
2007	4	0
2008	18	0
2009	8	0
2010	20	0
2011	18	0
2012	23	0
2013	24	0
2014	23	0
2015	24	0
2016	33	0
2017	18	0
2018	22	0
2019	16	0
2020	27	0
2021	20	0
2022	30	0
2023	24	0
2024	31	0
2025	42	0
2026	30	0

FIG. 1 — Lineage of K960413, 1990–2026Source: 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? (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
*	K923575	Coherent Versapluse 2.1 Holmium Surg. Lasers Summary page 1 …ccessories). Predicate Devices * Suction/Irrigation Probe (with long adapter/sizing sheath, short adapter and gasket) Accessory Kit marketed by Coherent Medical, Inc. (K923575, K902990) * LASE Surgical Kit (Model 1100 Discectomy Decompression Kit) manufactured by Clarus Medical Systems, Inc. (K913136)…	Coherent Medical Group	1993	—
*	K902990	Coherent Holmium:Yag Surgical Laser Summary page 1 …s). Predicate Devices * Suction/Irrigation Probe (with long adapter/sizing sheath, short adapter and gasket) Accessory Kit marketed by Coherent Medical, Inc. (K923575, K902990) * LASE Surgical Kit (Model 1100 Discectomy Decompression Kit) manufactured by Clarus Medical Systems, Inc. (K913136) Product D…	Coherent Medical Division	1990	—
*	K913136	Laser Endoscope Disc Decompression Kits Summary page 1 …ry Kit marketed by Coherent Medical, Inc. (K923575, K902990) * LASE Surgical Kit (Model 1100 Discectomy Decompression Kit) manufactured by Clarus Medical Systems, Inc. (K913136) Product Description The Coherent SlimLine Single Lumen Aspiration Needle Set and associated accessories are intended to be use…	Medical Laser, Inc.	1991	—

Also cleared against K923575: 2 other devices →

What descends from it? (483)

See all 483

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

Number	Device	Applicant	Decided	Descendants
K980685	Modified Versapulse Select HO:Yag and HO:Yag/ND:Yag Lasers	Lumenis, Inc.	1998	351
K990947	Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND…	Lumenis, Inc.	1999	350
K050738	FT Fiber Optic Delivery Systems	Fibertech GmbH	2005	225
K980838	Reusable Megabeam Fiber Optic Delivery System	Ceram Optec, 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?

None of the 3 ancestors has a recall.
Of its descendants, K980685 (Lumenis, Inc., 1998) has gone furthest, with 351 descendants of its own.
2 other devices also cite its predicate K923575.

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 Coherent SlimLine Single Lumen Aspiration Needle Set and the Delivery Accessories that are used with them to deliver light energy are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); arthroscopy (knee surgery); and open and endoscopic general surgery, and for aspiration and/ or irrigation of fluid and/or surgical debris.

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/K960413 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960413: Coherent Slimline Single Lumen Aspiration Needle Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960413

Report an extraction error

Are you the manufacturer?

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