510(k) · Cleared

Cleared

Uvisol and Uvisol II

K934808510(k) TraditionalCleared Dec 16, 199370-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

National Biological Corp. · FTC Light, Ultraviolet, Dermatological

Cleared on Dec 16, 1993 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 767 later devices descend from it.

Decided: Dec 16, 1993
Review: 70 days
Class: Class II
Product code: FTC
Recalls: None
Predicates: 0

767 later devices descend from it, 2 citing it directly.

This deviceK934808 Uvisol and Uvisol IINational Biological Corp. · 1993
Descendant · cites it directly · 766 of its ownK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
Descendant · 2 generations on · 759 of its ownK020591 BclearLumenis · 2002
Descendant · 2 generations on · 750 of its ownK021762 BclearLumenis, Inc. · 2002
Descendant · 3 generations on · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
Descendant · 3 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004

Showing 5 of 767 descendants. See all descendants

Descendants cleared per year

2000high 105 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 767 · See all

K992914Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000 · cites it directly766descendants
K020591BclearLumenis · 2002 · 2 generations on759descendants
K021762BclearLumenis, Inc. · 2002 · 2 generations on750descendants
K033946Lovely SystemMsq (M2), Ltd. · 2004 · 3 generations on737descendants
K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 3 generations on517descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K934808	Uvisol and Uvisol II	National Biological Corp.	1993	—
+1	K992914	Excimer Laser Phototherapy System, AL7000	Acculase, Inc.	2000	—
+2	K020591	Bclear	Lumenis	2002	—
+2	K021762	Bclear	Lumenis, Inc.	2002	—
+3	K033946	Lovely System	Msq (M2), Ltd.	2004	—
+3	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
2000	1	0
2002	4	0
2003	3	0
2004	5	0
2005	4	0
2006	6	0
2007	16	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 K934808, 1993–2026Source: 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? (767)

See all 767

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

Number	Device	Applicant	Decided	Descendants
K992914	Excimer Laser Phototherapy System, AL7000	Acculase, Inc.	2000	766
K020847	Xtrac Excimer Laser System, Model AL7000	Photo Medex, Inc.	2002	295

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, K992914 (Acculase, Inc., 2000) has gone furthest, with 766 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/K934808 · printed Nov 6, 2026

Cite this page

510(k) Report. “K934808: Uvisol and Uvisol II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934808

Report an extraction error

Are you the manufacturer?

Record history

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