510(k) · Cleared

Cleared

Omnilux Blue

K030883510(k) TraditionalCleared Jun 18, 200390-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

Photo Therapeutics Limited · GEX Powered Laser Surgical Instrument

Cleared on Jun 18, 2003 as substantially equivalent to K013623 (Curelight, Ltd., 2002) after a 90-day review. Its family tree reaches back 1 generation to 2002. 524 later devices descend from it.

Decided: Jun 18, 2003
Review: 90 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K013623 (2002). 524 later devices descend from it, 16 citing it directly.

By dateBy generation

Root · 1 generation backK013623 Clearlight Phototheraphy System, Model CL 420Curelight, Ltd. · 2002
This deviceK030883 Omnilux BluePhoto Therapeutics Limited · 2003
Descendant · cites it directly · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
Descendant · 3 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
Descendant · cites it directly · 169 of its ownK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
Descendant · 2 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007

Showing 5 of 524 descendants. See all descendants

Descendants cleared per year

2004high 84 (2025) · low 2 (2004)2026

Most influential descendants

Showing 5 of 524 · See all

K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · cites it directly402descendants
K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 2 generations on266descendants
K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 3 generations on198descendants
K081307Omnilux Clear-UPhoto Therapeutics, Inc. · 2009 · cites it directly169descendants
K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 2 generations on129descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K013623	Clearlight Phototheraphy System, Model CL 420	Curelight, Ltd.	2002	—
0 (this device)	K030883	Omnilux Blue	Photo Therapeutics Limited	2003	—
+1	K042630	Revlight Skin Care System	Skincare Technology, Inc.	2005	—
+2	K072564	Alma Lasers Harmony XL Multi-Application Platform	Alma Lasers, Ltd.	2008	—
+3	K083899	Revlite Q-Switched ND:Yag Laser System	Hoya Conbio, Inc.	2009	—
+1	K081307	Omnilux Clear-U	Photo Therapeutics, Inc.	2009	—
+2	K070388	Profile Multi-Platform System	Sciton, Inc	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	4	0
2006	2	0
2007	2	0
2008	12	0
2009	7	0
2010	11	0
2011	4	0
2012	6	0
2013	9	0
2014	14	0
2015	22	0
2016	21	0
2017	30	0
2018	27	0
2019	23	0
2020	30	0
2021	32	0
2022	43	0
2023	37	0
2024	52	0
2025	84	0
2026	50	0

FIG. 1 — Lineage of K030883, 2002–2026Source: 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
*	K013623	Clearlight Phototheraphy System, Model CL 420	Curelight, Ltd.	2002	—

Also cleared against K013623: 9 other devices →

What descends from it? (524)

See all 524

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

Number	Device	Applicant	Decided	Descendants
K042630	Revlight Skin Care System	Skincare Technology, Inc.	2005	402
K081307	Omnilux Clear-U	Photo Therapeutics, Inc.	2009	169
K041103	Acnelift	Inner Act, LLC	2004	116
K060792	Illumimed	Photoactif, LLC	2006	115
K083183	Aklarus Phototherapy System	Hill Laboratories Co.	2009	91
K051259	Versaclear Skin Therapy System, Model 100	Theralight, Inc.	2005	47
K120460	Smartlux	Medmix Co., Ltd.	2012	18
K082586	Lightwave Professional Deluxe	Lightwave Technologies, LLC	2010	4
K043575	Dermillume, Model PRO1000	Care Electronics, Inc.	2005	4
K092734	E-Light Line	Espansione Marketing S.P.A	2010	2

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, K042630 (Skincare Technology, Inc., 2005) has gone furthest, with 402 descendants of its own.
9 other devices also cite its predicate K013623.

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 Omnilux Blue is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030883 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030883: Omnilux Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030883

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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