510(k) · Cleared

Cleared

Dermaclear UV-B Phototherapy System

K011197510(k) TraditionalCleared Dec 14, 2001239-day reviewClass II21 CFR 878.4630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lumenis · FTC Light, Ultraviolet, Dermatological

Cleared on Dec 14, 2001 after a 239-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 762 later devices descend from it.

Decided: Dec 14, 2001
Review: 239 days
Class: Class II
Product code: FTC
Recalls: None
Predicates: 0

762 later devices descend from it, 3 citing it directly.

This deviceK011197 Dermaclear UV-B Phototherapy SystemLumenis · 2001
Descendant · cites it directly · 750 of its ownK021762 BclearLumenis, Inc. · 2002
Descendant · 2 generations on · 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 · 3 generations on · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
Descendant · 3 generations on · 302 of its ownK041969 Aurora DSSyneron Medical, Ltd. · 2004

Showing 5 of 762 descendants. See all descendants

Descendants cleared per year

2002high 105 (2025) · low 2 (2002)2026

Most influential descendants

Showing 5 of 762 · See all

K021762BclearLumenis, Inc. · 2002 · cites it directly750descendants
K033946Lovely SystemMsq (M2), Ltd. · 2004 · 2 generations on737descendants
K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · 3 generations on402descendants
K041969Aurora DSSyneron Medical, Ltd. · 2004 · 3 generations on302descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011197	Dermaclear UV-B Phototherapy System	Lumenis	2001	—
+1	K021762	Bclear	Lumenis, Inc.	2002	—
+2	K033946	Lovely System	Msq (M2), Ltd.	2004	—
+2	K042000	Modified MSQ Family of Lovely Light/Laser Systems	Msq (M2), Ltd.	2004	—
+3	K042630	Revlight Skin Care System	Skincare Technology, Inc.	2005	—
+3	K041969	Aurora DS	Syneron Medical, Ltd.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	2	0
2004	5	0
2005	4	0
2006	6	0
2007	15	0
2008	24	0
2009	14	0
2010	17	0
2011	18	0
2012	15	0
2013	24	0
2014	27	0
2015	26	0
2016	35	0
2017	35	0
2018	34	0
2019	23	0
2020	46	0
2021	37	0
2022	50	0
2023	49	0
2024	82	0
2025	105	0
2026	67	0

FIG. 1 — Lineage of K011197, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FTC? 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 FTC device

#1 K242977 308nm Excimer Phototherapy Device (CN-308E…score 14.8 · 21 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (762)

See all 762

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

Number	Device	Applicant	Decided	Descendants
K021762	Bclear	Lumenis, Inc.	2002	750
K020847	Xtrac Excimer Laser System, Model AL7000	Photo Medex, Inc.	2002	295
K062963	Pharos Excimer Laser System, Model EX-308	Ra Medical Systems,Inc	2007	3

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, K021762 (Lumenis, Inc., 2002) has gone furthest, with 750 descendants of its own.

How does its category compare?

All FTC devices

FTC Light, Ultraviolet, Dermatological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTC

3in 2025

2007high 5 (2011) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTC

76in 2025

2007high 237 (2020) · low 41 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTC

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTC

8in 2025

2007high 48 (2021) · low 0 (2007)2025

MAUDE reports naming product code FTC, 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	4	53	0	0
2008	3	41	1	0
2009	2	—	0	0
2010	1	—	0	2
2011	5	125	0	0
2012	1	—	0	1
2013	1	—	0	1
2014	2	—	0	1
2015	3	98	0	8
2016	1	—	0	2
2017	2	—	0	2
2018	3	88	0	0
2019	2	—	0	14
2020	5	237	0	4
2021	3	89	0	48
2022	1	—	0	4
2023	4	48	0	5
2024	1	—	0	4
2025	3	76	1	8
2026	4	91	3	—

https://510kreport.com/device/K011197 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011197: Dermaclear UV-B Phototherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011197

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026