510(k) · Cleared

Cleared

Lumenis Family of Disposable Contact Tip Delivery Devices

K030033510(k) TraditionalCleared Jul 21, 2003199-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, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Jul 21, 2003 as substantially equivalent to K022060 (Lumenis, Inc., 2002) and 8 other predicates after a 199-day review. Its family tree reaches back 8 generations to 1994.

Decided: Jul 21, 2003
Review: 199 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 9

Its longest line of descent runs back 8 generations to K936109 (1994). 75 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.

By dateBy generation

Root · 8 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
7 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
6 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
5 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
4 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
3 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
2 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
1 generation backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
This deviceK030033 Lumenis Family of Disposable Contact Tip Delivery DevicesLumenis, Ltd. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K936109	Sharplan Model 1120 CO2 Surgical Laser	Sharplan Lasers, Inc.	1994	—
−7	K960521	Sharplan Lasers, Inc. Silktouch Flash Scanner	Sharplan Lasers, Inc.	1996	—
−6	K963339	Coherent Ultrapulse CO2 Surgical Lasers	Coherent Medical Group	1997	—
−5	K974789	Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L	Lumenis, Inc.	1998	—
−4	K990947	Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO…	Lumenis, Inc.	1999	—
−3	K011703	Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…	Lumenis	2001	2
−2	K014290	Entec Plasma Wands	Arthrocare Corp.	2002	—
−1	K021364	Modification to Entec Plasma Wands	Arthrocare Corp.	2002	—
0 (this device)	K030033	Lumenis Family of Disposable Contact Tip Delivery Devices	Lumenis, Ltd.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1982	1	0
1986	1	0
1987	2	0
1988	2	0
1989	2	0
1990	2	0
1991	3	0
1992	3	0
1993	1	0
1994	7	0
1995	10	0
1996	10	0
1997	3	0
1998	8	0
1999	3	0
2000	5	0
2001	2	0
2002	1	0

FIG. 1 — Lineage of K030033, 1994–2003Source: 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? (9)

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
*	K022060	Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories Summary page 2 …, sterilization process, and system compatibility, and therefore is substantially equivalent to the OraVENT Fiber Delivery Devices manufactured by Lumenis (K022060), the predicate Series 2900 Synthetic Contact Tips manufactured by ESC Sharplan (K894211), the SLT Contact and Diffuser Ti…	Lumenis, Inc.	2002	—
*	K894211	Sharplan Series 2900 Synthetic Contact Tips Summary page 1 …Fiber Delivery Devices (used with the UltraPulse Series COZ Surgical Lasers, KO22060 and K974789); 0 ESC Sharplan Series 2900 Synthetic Contact Tips (K894211); 0 Surgical Laser Technologies (SLT) Contact and Diffuser Tips with Wavelength Conversion Surface Treatment…	Sharplan Lasers, Inc.	1989	—
*	K010041	SLT Diffuser Fiber Summary page 2 …, the predicate ESC Sharplan Series 2900 Synthetic Contact Tips (K8942 1l), the SLT Contact and Diffuser Tips with Wavelength Conversion surface treatment (K010041, K980156, K882212, K872254, and K872253), the Somnus Medical Technologies Somnoplasty System ( ~ 9 7 3 168), and the Arthr…	Surgical Laser Technologies, Inc.	2001	—
*	K980156	SLT Select Fiber Delivery System and Contact Tips Summary page 1 …nthetic Contact Tips (K894211); 0 Surgical Laser Technologies (SLT) Contact and Diffuser Tips with Wavelength Conversion Surface Treatment (KO 10041, K980 156, K8822 12, K872254, and K872253); 0 Somnus Medical Technologies Somnoplasty System (K973618); 0 Arth…	Surgical Laser Technologies, Inc.	1998	—
*	K882212	SLT Contact Laser System Summary page 1 …ntact Tips (K894211); 0 Surgical Laser Technologies (SLT) Contact and Diffuser Tips with Wavelength Conversion Surface Treatment (KO 10041, K980 156, K8822 12, K872254, and K872253); 0 Somnus Medical Technologies Somnoplasty System (K973618); 0 ArthroCare Cor…	Surgical Laser Technologies, Inc.	1988	—
*	K872254	SLT Contact ND:Yag Laser for Intra-Abdom.&Genital Summary page 1 …(K894211); 0 Surgical Laser Technologies (SLT) Contact and Diffuser Tips with Wavelength Conversion Surface Treatment (KO 10041, K980 156, K8822 12, K872254, and K872253); 0 Somnus Medical Technologies Somnoplasty System (K973618); 0 ArthroCare Corporation…	Surgical Laser Technologies, Inc.	1987	—
*	K872253	Contact ND:Yag Laser for Treatment of Menorrhagia Summary page 1 …urgical Laser Technologies (SLT) Contact and Diffuser Tips with Wavelength Conversion Surface Treatment (KO 10041, K980 156, K8822 12, K872254, and K872253); 0 Somnus Medical Technologies Somnoplasty System (K973618); 0 ArthroCare Corporation Bipolar Electrosurgical…	Surgical Laser Technologies, Inc.	1987	—
*	K973618	Somnoplasty System Summary page 1 …ength Conversion Surface Treatment (KO 10041, K980 156, K8822 12, K872254, and K872253); 0 Somnus Medical Technologies Somnoplasty System (K973618); 0 ArthroCare Corporation Bipolar Electrosurgical ENTec Plasma Wands (KO2 1364). Iv. Product Description Lume…	Somnus Medical Technologies, Inc.	1997	—
*	K021364	Modification to Entec Plasma Wands Summary page 2 …K010041, K980156, K882212, K872254, and K872253), the Somnus Medical Technologies Somnoplasty System ( ~ 9 7 3 168), and the ArthroCare ENTec Plasma Wands (K021364). The Lumenis Family of Disposable Contact Tip Delivery Devices for C02 Lasers shares similar indications for use in surgi…	Arthrocare Corp.	2002	—

Also cleared against K022060: 20 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 9 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
2 of the 75 ancestors have a recall of any class.
20 other devices also cite its predicate K022060.

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 Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers is indicated for use in surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue using laser-generated thermal energy in medical specialties, including aesthetic (dermatology and .plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery, for the indications for use that the compatible laser system to which attached has been cleared.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030033 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030033: Lumenis Family of Disposable Contact Tip Delivery Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030033

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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