510(k) · Cleared

Cleared

Skinclear Q-Switched ND:Yag Laser

K083272510(k) TraditionalCleared Dec 16, 200840-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

Global USA Distribution, LLC · GEX Powered Laser Surgical Instrument

Cleared on Dec 16, 2008 as substantially equivalent to K041011 (Sandstone Medical Technologies, LLC, 2004) after a 40-day review. Its family tree reaches back 4 generations to 1995.

Decided: Dec 16, 2008
Review: 40 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K950019 (1995). 8 ancestors in all, the oldest K942622 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
3 generations backK973719 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag LaserContinuum Biomedical, Inc. · 1997
2 generations backK983054 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag LaserContinuum Biomedical, Inc. · 1999
1 generation backK041011 Ultralight II ND:Yag Laser SystemSandstone Medical Technologies, LLC · 2004
This deviceK083272 Skinclear Q-Switched ND:Yag LaserGlobal USA Distribution, LLC · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K950019	Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100	Thermolase Corp.	1995	—
−3	K973719	Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag Laser	Continuum Biomedical, Inc.	1997	—
−2	K983054	Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser	Continuum Biomedical, Inc.	1999	—
−1	K041011	Ultralight II ND:Yag Laser System	Sandstone Medical Technologies, LLC	2004	—
0 (this device)	K083272	Skinclear Q-Switched ND:Yag Laser	Global USA Distribution, LLC	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1997	1	0
2001	2	0

FIG. 1 — Lineage of K083272, 1995–2008Source: 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
*	K041011	Ultralight II ND:Yag Laser System Summary page 1 …Instrument, Powered, Laser Legally Marketed Predicate Devices: Sandstone Medical Technologies, LLC UltraLight IINd:YAG Laser System (K04101 1) Description of the SkinClear Q-Switched Nd:YAG Laser: The SkinClear Q-Switched Nd:YAG Laser is composed of a console which hou…	Sandstone Medical Technologies, LLC	2004	—

Also cleared against K041011: 1 other device →

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 13 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
None of the 8 ancestors has a recall.
1 other device also cites its predicate K041011.

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. 2008, 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 SkinClear Q-Switched Nd:YAG Laser is indicated at the 1064 nm wavelength for dark ink tattoo removal, the removal of pigmented lesions, and the removal or lightening of hair. Indicated for use on all skin types (Fitzpatrick I-IV)

The SkinClear Q-Switched Nd:YAG Laser is indicated at the 532 nm wavelength for red ink tattoo removal, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, ephildes). Indicated for use on all skin types (Fitzpatrick I-IV)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083272 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083272: Skinclear 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/K083272

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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