510(k) · Cleared

Cleared

Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag Laser

K973719510(k) TraditionalCleared Dec 23, 199784-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 Dec 23, 1997 as substantially equivalent to K950019 (Thermolase Corp., 1995) after an 84-day review. Its family tree reaches back 1 generation to 1995. 749 later devices descend from it.

Decided: Dec 23, 1997
Review: 84 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K950019 (1995). 749 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
This deviceK973719 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag LaserContinuum Biomedical, Inc. · 1997
Descendant · cites it directly · 748 of its ownK983054 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag LaserContinuum Biomedical, Inc. · 1999
Descendant · 2 generations on · 742 of its ownK022709 Medlite Q-Swithced LaserContinuum Electro-Optics, Inc. · 2003
Descendant · cites it directly · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
Descendant · 2 generations on · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005

Showing 5 of 749 descendants. See all descendants

Descendants cleared per year

1999high 105 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 749 · See all

K983054Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag LaserContinuum Biomedical, Inc. · 1999 · cites it directly748descendants
K022709Medlite Q-Swithced LaserContinuum Electro-Optics, Inc. · 2003 · 2 generations on742descendants
K033946Lovely SystemMsq (M2), Ltd. · 2004 · cites it directly737descendants
K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · 2 generations on402descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950019	Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100	Thermolase Corp.	1995	—
0 (this device)	K973719	Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag Laser	Continuum Biomedical, Inc.	1997	—
+1	K983054	Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser	Continuum Biomedical, Inc.	1999	—
+2	K022709	Medlite Q-Swithced Laser	Continuum Electro-Optics, Inc.	2003	—
+1	K033946	Lovely System	Msq (M2), Ltd.	2004	—
+2	K042000	Modified MSQ Family of Lovely Light/Laser Systems	Msq (M2), Ltd.	2004	—
+2	K042630	Revlight Skin Care System	Skincare Technology, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2003	1	0
2004	5	0
2005	4	0
2006	7	0
2007	13	0
2008	24	0
2009	13	0
2010	17	0
2011	19	0
2012	15	0
2013	25	0
2014	27	0
2015	26	0
2016	35	0
2017	33	0
2018	32	0
2019	23	0
2020	43	0
2021	37	0
2022	50	0
2023	47	0
2024	82	0
2025	105	0
2026	65	0

FIG. 1 — Lineage of K973719, 1995–2026Source: 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
*	K950019	Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 Summary page 1 …edlite™ IV Q-Switched Nd:YAG Laser Medical laser system Instrument, surgical, powered, laser 79-GEX 21 CRF 878.48 ThermoLase LT-100 Nd:YAG Laser Hair Removal System (K950019, SE Date 04-03-95) For the removal or lightening of unwanted hair Equivalent None Authorization provided to access data in K95…	Thermolase Corp.	1995	—

Also cleared against K950019: 7 other devices →

What descends from it? (749)

See all 749

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

Number	Device	Applicant	Decided	Descendants
K983054	Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser	Continuum Biomedical, Inc.	1999	748
K033946	Lovely System	Msq (M2), Ltd.	2004	737

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, K983054 (Continuum Biomedical, Inc., 1999) has gone furthest, with 748 descendants of its own.
7 other devices also cite its predicate K950019.

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 the removal or lightening of unwanted hair in the 1064nm mode only.

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/K973719 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973719: Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973719

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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