510(k) · Cleared

Cleared

CLARO

K080638510(k) TraditionalCleared Sep 17, 2008195-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

Clrs Technology Corporation · GEX Powered Laser Surgical Instrument

Cleared on Sep 17, 2008 as substantially equivalent to K060411 (Radiancy (Israel), Ltd., 2006) and 5 other predicates after a 195-day review. Its family tree reaches back 7 generations to 1992. 2 later devices descend from it.

Decided: Sep 17, 2008
Review: 195 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 6

Its longest line of descent runs back 7 generations to K910422 (1992). 62 ancestors in all, the oldest K892514 (1990). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 7 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
6 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
5 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
4 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
3 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
2 generations backK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
1 generation backK041086 Palomar Starlux Pulsed Light SystemPalomar Medical Products, Inc. · 2005
This deviceK080638 CLAROClrs Technology Corporation · 2008
Descendant · cites it directly · 1 of its ownK090744 CLAROClrs Technology Corporation · 2010
Descendant · 2 generations on · 0 of its ownK150282 Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc. · 2015

Most influential descendants

Showing 2 of 2 · See all

K090744CLAROClrs Technology Corporation · 2010 · cites it directly1descendant
K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K910422	Model RD-1200 Ruby Laser System	Spectrum Medical Technologies, Inc.	1992	—
−6	K961279	Sharplan Lasers, Inc. Ruby Laser System	Sharplan Lasers, Inc.	1996	—
−5	K962446	Sharplan Ruby Laser System	Sharplan Lasers, Inc.	1997	—
−4	K974536	Photoderm HR System	Esc Medical Systems, Ltd.	1998	—
−3	K991935	Epilight Hair Removal System, Photoderm HR System	Esc Medical Systems, Ltd.	2000	—
−2	K020839	Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL	Lumenis, Inc.	2002	—
−1	K041086	Palomar Starlux Pulsed Light System	Palomar Medical Products, Inc.	2005	—
0 (this device)	K080638	CLARO	Clrs Technology Corporation	2008	—
+1	K090744	CLARO	Clrs Technology Corporation	2010	—
+2	K150282	Shaser Skin Beauty Intense Pulsed Light System Family for Acne	Shaser, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1991	3	0
1993	3	0
1994	7	0
1995	6	0
1996	7	0
1997	6	0
1998	5	0
1999	3	0
2000	3	0
2001	2	0
2002	1	0
2003	1	0
2004	2	0
2005	2	0
2006	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2015	1	0

FIG. 1 — Lineage of K080638, 1992–2015Source: 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? (6)

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
*	K060411	Radiancy Cleartouch Lite Acne Clearance System Summary page 1 …Product Code: GEX 3. Predicate Devices The CLARO is substantially equivalent to a combination of the Radiancy ClearTouch Lite Acne Clearance System (K06041 1), the Tyrell, Incorporation Zeno Acne Device (K043377) the DermaCare, Inc. ThermaClear Device (K060653), the Palomar…	Radiancy (Israel), Ltd.	2006	—
*	K043377	ZENO Summary page 1 …RO is substantially equivalent to a combination of the Radiancy ClearTouch Lite Acne Clearance System (K06041 1), the Tyrell, Incorporation Zeno Acne Device (K043377) the DermaCare, Inc. ThermaClear Device (K060653), the Palomar StarLux with LuxV Handpiece (KO4008 1 and K04 1086), a…	Tyrell, Inc.	2005	—
*	K060653	Thermaclear Summary page 1 …Radiancy ClearTouch Lite Acne Clearance System (K06041 1), the Tyrell, Incorporation Zeno Acne Device (K043377) the DermaCare, Inc. ThermaClear Device (K060653), the Palomar StarLux with LuxV Handpiece (KO4008 1 and K04 1086), and the Quanta System Eterna Giovinezza System (KO5 1113…	Dermacare, Inc.	2006	—
*	K040081	Palomar Luxv Handpiece	Palomar Medical Technologies, Inc.	2004	—
*	K041086	Palomar Starlux Pulsed Light System Summary page 1 …the Tyrell, Incorporation Zeno Acne Device (K043377) the DermaCare, Inc. ThermaClear Device (K060653), the Palomar StarLux with LuxV Handpiece (KO4008 1 and K04 1086), and the Quanta System Eterna Giovinezza System (KO5 1113). 4. Device Description The CLARO is a portable handhel…	Palomar Medical Products, Inc.	2005	—
*	K051113	Quanta System Etrna Giovinezza	Quanta System Spa	2006	1

Also cleared against K060411: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K090744	CLARO	Clrs Technology Corporation	2010	1

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 6 companies; a new generation was cleared every 2.3 years on median.
2 of the 62 ancestors have a recall of any class.
Of its descendants, K090744 (Clrs Technology Corporation, 2010) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K060411.

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 CLARO is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080638 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080638: CLARO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080638

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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