510(k) · Cleared

Cleared

Wavelight Idas

K053604510(k) TraditionalCleared Feb 22, 200657-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

Wavelight Laser Technologie AG · GEX Powered Laser Surgical Instrument

Cleared on Feb 22, 2006 as substantially equivalent to K951034 (Laserscope, 1995) after a 57-day review. Its family tree reaches back 1 generation to 1995. 72 later devices descend from it.

Decided: Feb 22, 2006
Review: 57 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K951034 (1995). 72 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK951034 Aura Laser SystemLaserscope · 1995
This deviceK053604 Wavelight IdasWavelight Laser Technologie AG · 2006
Descendant · cites it directly · 68 of its ownK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
Descendant · 2 generations on · 46 of its ownK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
Descendant · 3 generations on · 26 of its ownK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
Descendant · 4 generations on · 24 of its ownK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
Descendant · 4 generations on · 23 of its ownK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013

Showing 5 of 72 descendants. See all descendants

Descendants cleared per year

2010high 13 (2025) · low 1 (2012)2026

Most influential descendants

Showing 5 of 72 · See all

K100558Quanta Diode Laser SystemQuanta System Spa · 2010 · cites it directly68descendants
K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc. · 2010 · 2 generations on46descendants
K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011 · 3 generations on26descendants
K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012 · 4 generations on24descendants
K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc. · 2013 · 4 generations on23descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951034	Aura Laser System	Laserscope	1995	—
0 (this device)	K053604	Wavelight Idas	Wavelight Laser Technologie AG	2006	—
+1	K100558	Quanta Diode Laser System	Quanta System Spa	2010	—
+2	K102755	Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…	Biolitec, Inc.	2010	—
+3	K110080	Radial-Emitting Shaped Fiber Optic Delivery System	Biolitec, Inc.	2011	—
+4	K120810	Fiberoptic Laser Delivery System	Fiberoptic Fabrications, Inc.	2012	—
+4	K124003	Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers…	Med-Fibers, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	0
2011	3	0
2012	1	0
2013	6	0
2014	4	0
2015	3	0
2016	7	0
2017	2	0
2018	2	0
2019	1	0
2020	2	0
2021	2	0
2022	6	0
2023	4	0
2024	10	0
2025	13	0
2026	4	0

FIG. 1 — Lineage of K053604, 1995–2026Source: 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
*	K951034	Aura Laser System Summary page 1 …Panel: Dermatology and Plastic Surgery 3. Predicate Devices The IDAS laser system is substantially equivalent to the Laserscope laser system AURA (K951034). 4. Device Description The IDAS laser system (532 nm) is used for the treatment of superficial vascular lesions…	Laserscope	1995	—

Also cleared against K951034: 7 other devices →

What descends from it? (72)

See all 72

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

Number	Device	Applicant	Decided	Descendants
K100558	Quanta Diode Laser System	Quanta System Spa	2010	68
K230308	Alma Harmony	Alma Lasers, Inc.	2023	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, K100558 (Quanta System Spa, 2010) has gone furthest, with 68 descendants of its own.
7 other devices also cite its predicate K951034.

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 IDAS laser system is intended for use for

Aesthetics:

vascular lesions, spider veins, spider naevi, teleangiectasis, red superficial veins of

the legs and face, pigmented lesions (e.g. caf6-au-lait stains, lentigo), hemangiomas,

port wine stains, rosacea.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053604 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053604: Wavelight Idas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053604

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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