510(k) · Cleared

Cleared

Aura Laser System

K951034510(k) TraditionalCleared Apr 13, 199538-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

Laserscope · GEX Powered Laser Surgical Instrument

Cleared on Apr 13, 1995 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 314 later devices descend from it.

Decided: Apr 13, 1995
Review: 38 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

314 later devices descend from it, 8 citing it directly.

This deviceK951034 Aura Laser SystemLaserscope · 1995
Descendant · cites it directly · 308 of its ownK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
Descendant · cites it directly · 307 of its ownK964074 Diolite 532Iriderm Div. · 1997
Descendant · 2 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Descendant · 3 generations on · 92 of its ownK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled

Showing 5 of 314 descendants. See all descendants

Descendants cleared per year

1996high 35 (2025) · low 0 (1999)2026

Most influential descendants

Showing 5 of 314 · See all

K954905CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996 · cites it directly308descendants
K964074Diolite 532Iriderm Div. · 1997 · cites it directly307descendants
K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 2 generations on198descendants
K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · 3 generations on92descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K951034	Aura Laser System	Laserscope	1995	—
+1	K954905	CB Diode/532 Laser System	Continuum Biomedical, Inc.	1996	—
+1	K964074	Diolite 532	Iriderm Div.	1997	—
+2	K083899	Revlite Q-Switched ND:Yag Laser System	Hoya Conbio, Inc.	2009	—
+3	K101916	Joule Multi-Platform System	Sciton, Inc	2011	—
+3	K103118	Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor	Hoya Photonics, Inc.	2010	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	2	0
1998	2	0
2002	3	0
2003	1	0
2004	3	0
2006	2	0
2007	2	0
2008	1	0
2009	2	0
2010	6	0
2011	7	0
2012	4	0
2013	11	0
2014	16	0
2015	13	0
2016	17	0
2017	17	0
2018	15	0
2019	15	0
2020	19	0
2021	17	0
2022	32	0
2023	15	0
2024	33	0
2025	35	0
2026	23	0

FIG. 1 — Lineage of K951034, 1995–2026Source: 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 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?

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

What descends from it? (314)

See all 314

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

Number	Device	Applicant	Decided	Descendants
K954905	CB Diode/532 Laser System	Continuum Biomedical, Inc.	1996	308
K964074	Diolite 532	Iriderm Div.	1997	307
K041930	Varilite Laser System	Iridex Corporation	2004	75
K053604	Wavelight Idas	Wavelight Laser Technologie AG	2006	72
K021975	Lasersystem Beautystar 532	Asclepion-Meditec AG	2002	24
K982031	Oculight GL with the Dermatology Handpiece	Iridex Corp	1998	22
K192272	Wolf445nm	A.R.C Laser GmbH	2020	6
K972368	Fotona Skinlight Plus ND: Yag System	Medical Laser Solutions	1997	0

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, K954905 (Continuum Biomedical, Inc., 1996) has gone furthest, with 308 descendants of its own.

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	—

https://510kreport.com/device/K951034 · printed Nov 5, 2026

Cite this page

510(k) Report. “K951034: Aura Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951034

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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