510(k) · Cleared

Cleared

Noveon, Model LS1100-01-0968

K071815510(k) TraditionalCleared Nov 28, 2007149-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

Nomir Medical Technologies, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Nov 28, 2007 as substantially equivalent to K032864 (Biolitec, Inc., 2004) and 6 other predicates after a 149-day review. Its family tree reaches back 3 generations to 1991.

Decided: Nov 28, 2007
Review: 149 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 7

Its longest line of descent runs back 3 generations to K912538 (1991). 18 ancestors in all, the oldest K901710 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK912538 KTP/Yag PlusLaserscope · 1991
2 generations backK972575 800 Series Surgical Laser System Orion Series Surgical Laser System…Laserscope · 1998
1 generation backK062363 BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NMB&W Tek, Inc. · 2007
This deviceK071815 Noveon, Model LS1100-01-0968Nomir Medical Technologies, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K912538	KTP/Yag Plus	Laserscope	1991	—
−2	K972575	800 Series Surgical Laser System Orion Series Surgical Laser System Angled…	Laserscope	1998	—
−1	K062363	BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NM	B&W Tek, Inc.	2007	—
0 (this device)	K071815	Noveon, Model LS1100-01-0968	Nomir Medical Technologies, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1992	1	0
1993	1	0
1994	1	0
1995	3	0
2001	1	0
2002	1	0
2004	2	0
2005	1	0
2006	3	0

FIG. 1 — Lineage of K071815, 1991–2007Source: 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? (7)

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
*	K032864	Ceralas D 810 Diode Laser System, Model D15 Summary page 1 …Classification Panel: General and Plastic Surgery Devices CFR Section: 21 CFR 870.4810 Class: H1 Product Code: GEX Predicate Devices * Ceralas D 810 Diode Laser System, K032864, by Biolitec, Inc * LaserPro 810, 940, and 980 Dioxide Laser Systems, K040294, by Photomedex, Inc * Vectra Laser System, K0601 14…	Biolitec, Inc.	2004	—
*	K040294	Laserpro Diode Laser Systems, Models 810, 940 & 980 Summary page 1 …870.4810 Class: H1 Product Code: GEX Predicate Devices * Ceralas D 810 Diode Laser System, K032864, by Biolitec, Inc * LaserPro 810, 940, and 980 Dioxide Laser Systems, K040294, by Photomedex, Inc * Vectra Laser System, K0601 14, by Xintee Corporation * BWF-5 Medical Laser Series, K062363, by B&W Tek Inc…	Photo Medex, Inc.	2004	—
*	K060114	Vectra Laser System Summary page 1 …ices * Ceralas D 810 Diode Laser System, K032864, by Biolitec, Inc * LaserPro 810, 940, and 980 Dioxide Laser Systems, K040294, by Photomedex, Inc * Vectra Laser System, K0601 14, by Xintee Corporation * BWF-5 Medical Laser Series, K062363, by B&W Tek Inc * PhoTexiS Diode Laser Series: 980, 810, 940, K060…	Xintec Corporation, Dba,	2006	—
*	K062363	BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NM Summary page 1 …Inc * LaserPro 810, 940, and 980 Dioxide Laser Systems, K040294, by Photomedex, Inc * Vectra Laser System, K0601 14, by Xintee Corporation * BWF-5 Medical Laser Series, K062363, by B&W Tek Inc * PhoTexiS Diode Laser Series: 980, 810, 940, K060304, by BioTex Inc * QYAG 5 Nd:YAG Laser System, K<061436, by…	B&W Tek, Inc.	2007	—
*	K060304	Photex Diode Laser Series, Models 980, 810 and 940 Summary page 1 …tomedex, Inc * Vectra Laser System, K0601 14, by Xintee Corporation * BWF-5 Medical Laser Series, K062363, by B&W Tek Inc * PhoTexiS Diode Laser Series: 980, 810, 940, K060304, by BioTex Inc * QYAG 5 Nd:YAG Laser System, K<061436, by Palomar Medical Technologies, Inc * Medlite C3 Q Switched Nd:YAG Laser,…	Biotex, Inc.	2006	—
*	K061436	Palomar Q-Yag 5 ND:Yag Laser System Summary page 1 …Corporation * BWF-5 Medical Laser Series, K062363, by B&W Tek Inc * PhoTexiS Diode Laser Series: 980, 810, 940, K060304, by BioTex Inc * QYAG 5 Nd:YAG Laser System, K<061436, by Palomar Medical Technologies, Inc * Medlite C3 Q Switched Nd:YAG Laser, KOl 1677, by Continuum Electro-Optics, hic (now H…	Palomar Medical Technologies, Inc.	2006	—
*	K011677	Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag Laser	Continuum Electro-Optics, Inc.	2001	—

Also cleared against K032864: 3 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 16 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
None of the 18 ancestors has a recall.
3 other devices also cite its predicate K032864.

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. 2007, this device’s year, is highlighted.

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 NoveonTM (Model LS1 100-01-0968) delivers continuous wave laser light in the contact or

non-contact mode during surgical procedures of the skin, subcutaneous tissues and nasal

passages in dermatology, plastic surgery, podiatry and otolaryngology. The device is indicated

for use in applications requiring incision, excision, vaporization, hemostasis, or coagulation of

soft tissue.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071815 · printed Nov 3, 2026

Cite this page

510(k) Report. “K071815: Noveon, Model LS1100-01-0968.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K071815

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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