510(k) · Cleared

Cleared

Softlight Q-Switched (ND:Yag) Laser

K971207510(k) TraditionalCleared May 13, 1998412-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

Thermolase Corp. · GEX Powered Laser Surgical Instrument

Cleared on May 13, 1998 after a 412-day review. The FDA summary names its predicate without a number. 781 later devices descend from it.

Decided: May 13, 1998
Review: 412 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

781 later devices descend from it, 4 citing it directly.

This deviceK971207 Softlight Q-Switched (ND:Yag) LaserThermolase Corp. · 1998
Descendant · cites it directly · 742 of its ownK022709 Medlite Q-Swithced LaserContinuum Electro-Optics, Inc. · 2003
Descendant · 2 generations on · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
Descendant · cites it directly · 554 of its ownK023967 Palomar Q-Yag ND:Yag Laser SystemPalomar Medical Technologies, Inc. · 2003
Descendant · 2 generations on · 519 of its ownK033251 The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004

Showing 5 of 781 descendants. See all descendants

Descendants cleared per year

2003high 109 (2025) · low 2 (2003)2026

Most influential descendants

Showing 5 of 781 · See all

K022709Medlite Q-Swithced LaserContinuum Electro-Optics, Inc. · 2003 · cites it directly742descendants
K033946Lovely SystemMsq (M2), Ltd. · 2004 · 2 generations on737descendants
K023967Palomar Q-Yag ND:Yag Laser SystemPalomar Medical Technologies, Inc. · 2003 · cites it directly554descendants
K033251The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004 · 2 generations on519descendants
K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K971207	Softlight Q-Switched (ND:Yag) Laser	Thermolase Corp.	1998	—
+1	K022709	Medlite Q-Swithced Laser	Continuum Electro-Optics, Inc.	2003	—
+2	K033946	Lovely System	Msq (M2), Ltd.	2004	—
+1	K023967	Palomar Q-Yag ND:Yag Laser System	Palomar Medical Technologies, Inc.	2003	—
+2	K033251	The Friendlylight ND: Yag Lasers	Innotech USA, Inc.	2004	—
+2	K042000	Modified MSQ Family of Lovely Light/Laser Systems	Msq (M2), Ltd.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	5	0
2005	4	0
2006	8	0
2007	13	0
2008	23	0
2009	14	0
2010	17	0
2011	19	0
2012	18	0
2013	25	0
2014	29	0
2015	27	0
2016	36	0
2017	36	0
2018	33	0
2019	25	0
2020	47	0
2021	39	0
2022	54	0
2023	50	0
2024	82	0
2025	109	0
2026	66	0

FIG. 1 — Lineage of K971207, 1998–2026Source: 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
*	—	ThermoLase SoftLight Q-Switched Nd:YAG Laser System Named without a submission number			—

What descends from it? (781)

See all 781

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

Number	Device	Applicant	Decided	Descendants
K022709	Medlite Q-Swithced Laser	Continuum Electro-Optics, Inc.	2003	742
K023967	Palomar Q-Yag ND:Yag Laser System	Palomar Medical Technologies, Inc.	2003	554
K150212	DeScribe Transparent PFD Patch	On Light Sciences, Inc.	2015	3
K192620	SNA-001 Silver Photoparticle Topical Gel	Sienna Biopharmaceuticals, Inc.	2020	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?

Of its descendants, K022709 (Continuum Electro-Optics, Inc., 2003) has gone furthest, with 742 descendants of its own.

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 SoftLight Q-switched Nd:YAG laser is indicated for use in combination with the supplied lotion for skin resurfacing. It is also indicated for the removal or lightening of unwanted facial or body hair.

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/K971207 · printed Nov 6, 2026

Cite this page

510(k) Report. “K971207: Softlight 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/K971207

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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