510(k) · Cleared

Cleared

Medlite/Erbium Laser System

K961748510(k) TraditionalCleared Jul 26, 199681-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

Continuum Biomedical, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jul 26, 1996 as substantially equivalent to K954013 (Schwartz Electro-Optics, Inc., 1996) after an 81-day review. Its family tree reaches back 1 generation to 1996. 1,230 later devices descend from it.

Decided: Jul 26, 1996
Review: 81 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K954013 (1996). 1,230 later devices descend from it, 10 citing it directly.

By dateBy generation

Root · 1 generation backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
This deviceK961748 Medlite/Erbium Laser SystemContinuum Biomedical, Inc. · 1996
Descendant · cites it directly · 1,142 of its ownK972347 Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc. · 1997
Descendant · 2 generations on · 1,064 of its ownK001589 Candela Dynamic Cooling DeviceCandela Corp. · 2000
Descendant · 3 generations on · 1,046 of its ownK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
Descendant · 4 generations on · 856 of its ownK030527 Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003
Descendant · 4 generations on · 756 of its ownK030342 Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · Recalled

Showing 5 of 1,230 descendants. See all descendants

Descendants cleared per year

1997high 130 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 1,230 · See all

K972347Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc. · 1997 · cites it directly1,142descendants
K001589Candela Dynamic Cooling DeviceCandela Corp. · 2000 · 2 generations on1,064descendants
K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002 · 3 generations on1,046descendants
K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003 · 4 generations on856descendants
K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · 4 generations on756descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954013	Trilase 2940 Erbium Laser	Schwartz Electro-Optics, Inc.	1996	—
0 (this device)	K961748	Medlite/Erbium Laser System	Continuum Biomedical, Inc.	1996	—
+1	K972347	Modified Coherent Versapulse Aesthetic Surgical Laser	Lumenis, Inc.	1997	—
+2	K001589	Candela Dynamic Cooling Device	Candela Corp.	2000	—
+3	K020839	Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL	Lumenis, Inc.	2002	—
+4	K030527	Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems	Lumenis	2003	—
+4	K030342	Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems	Lumenis, Ltd.	2003	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	8	0
1998	5	0
1999	2	0
2000	2	0
2002	8	0
2003	14	0
2004	15	0
2005	23	0
2006	25	0
2007	27	0
2008	45	0
2009	33	0
2010	34	0
2011	37	0
2012	35	0
2013	42	0
2014	47	0
2015	50	0
2016	56	0
2017	63	0
2018	54	0
2019	41	0
2020	57	0
2021	51	0
2022	85	0
2023	70	0
2024	94	0
2025	130	0
2026	77	0

FIG. 1 — Lineage of K961748, 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

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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
*	K954013	Trilase 2940 Erbium Laser Summary page 1 …y 12, 1996 Medlite\Erbium Laser System Dermatology laser system Instrument, surgical, powered, laser 79-GEX 21 CFR 878.48 SEO Medical TriLase 2940 Erbium Laser System (K954013) The Medlite\Erbium Laser is an erbium laser producing laser emissions at 2.94u. The laser consists of three interconnected sect…	Schwartz Electro-Optics, Inc.	1996	—

Also cleared against K954013: 13 other devices →

What descends from it? (1,230)

See all 1,230

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

Number	Device	Applicant	Decided	Descendants
K972347	Modified Coherent Versapulse Aesthetic Surgical Laser	Lumenis, Inc.	1997	1,142
K974641	Futurelase 3000/3002 Erbium Laser System	Buckman Co., Inc.	1998	241
K980361	Dermablate ER: Yag Laser System	Aesculap-Meditec North America	1998	178
K964128	MCL 29 Dermablate Erbium Laser System	Aesculap-Meditec GmbH	1997	67
K971648	Sharplan Erbium: Yag Laser (4020)	Sharplan Lasers, Inc.	1997	58
K971459	Dermalase	Endo Technic Corp.	1997	6
K964253	Derma 20 Laser System	Esc Medical Systems, Ltd.	1997	1
K974460	Lite Touch Erbium Laser Treatment System	Lorad Corp.	1998	0
K972915	Erbium 2000 Laser Family	Phantom Technologies, Inc.	1997	0
K973576	Epulse Model 2940 ER:Aser ER:Yag Laser System	Epulse Technologies, Inc.	1997	0

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, K972347 (Lumenis, Inc., 1997) has gone furthest, with 1,142 descendants of its own.
13 other devices also cite its predicate K954013.

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?

For use in dermatology for the incision, excision, ablation, vaporization and hemostasis of soft tissue.

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/K961748 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961748: Medlite/Erbium Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961748

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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