510(k) · Cleared

Cleared

Dual Yellow Laser, Model Dual Yellow D10B

K032397510(k) TraditionalCleared May 27, 2004297-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

Norseld Pty., Ltd. · GEX Powered Laser Surgical Instrument

Cleared on May 27, 2004 as substantially equivalent to K000811 (Sls Biophile, Ltd., 2000) and 12 other predicates after a 297-day review. Its family tree reaches back 6 generations to 1991. 2 later devices descend from it.

Decided: May 27, 2004
Review: 297 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 13

Its longest line of descent runs back 6 generations to K904627 (1991). 52 ancestors in all, the oldest K882160 (1988). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 6 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
5 generations backK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
4 generations backK972347 Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc. · 1997
3 generations backK993671 Candela Sclero Long Pulse Dye LaserCandela Corp. · 2000
2 generations backK013748 Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002
1 generation backK021180 Candela Vbeam Pulsed Dye Laser SystemCandela Corp. · 2002
This deviceK032397 Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd. · 2004
Descendant · cites it directly · 1 of its ownK132976 AdvatxAdvalight Aps · 2014
Descendant · 2 generations on · 0 of its ownK250189 AdvaTxAdvalight Aps · 2025

Most influential descendants

Showing 2 of 2 · See all

K132976AdvatxAdvalight Aps · 2014 · cites it directly1descendant
K250189AdvaTxAdvalight Aps · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K904627	Centauri Yag Laser Syst, Ear, Nose , Throat	Pfizer Laser Systems	1991	—
−5	K960032	Coherent Versapulse Aesthetic Surgical Lasers	Coherent Medical Group	1996	—
−4	K972347	Modified Coherent Versapulse Aesthetic Surgical Laser	Lumenis, Inc.	1997	—
−3	K993671	Candela Sclero Long Pulse Dye Laser	Candela Corp.	2000	—
−2	K013748	Candela Sclero Long Pulse Laser (Aka Vbeam)	Candela Corp.	2002	—
−1	K021180	Candela Vbeam Pulsed Dye Laser System	Candela Corp.	2002	—
0 (this device)	K032397	Dual Yellow Laser, Model Dual Yellow D10B	Norseld Pty., Ltd.	2004	—
+1	K132976	Advatx	Advalight Aps	2014	—
+2	K250189	AdvaTx	Advalight Aps	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	2	0
1990	1	0
1991	2	0
1992	1	0
1993	2	0
1994	10	0
1995	6	0
1996	4	0
1997	2	0
1998	5	0
1999	2	0
2000	2	0
2001	2	0
2002	4	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2025	1	0

FIG. 1 — Lineage of K032397, 1991–2025Source: 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? (13)

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
*	K000811	Nlite System, SLS Model Number A00-1025 Summary page 1 …device 21 CFR 878.4810 Product Code: GEX Panel: 79 Predicate devices: ICN (and SLS BIOPHILE) NLite Laser Systems (K0008 11, K020729, K013461, K014130); Candela Vbeam (K021180), and Norseld Dual Yellow Laser (K02389…	Sls Biophile, Ltd.	2000	—
*	K020729	Nlite System,Model A00-1051 Summary page 1 …21 CFR 878.4810 Product Code: GEX Panel: 79 Predicate devices: ICN (and SLS BIOPHILE) NLite Laser Systems (K0008 11, K020729, K013461, K014130); Candela Vbeam (K021180), and Norseld Dual Yellow Laser (K023899); Ascle…	Icn Photonics, Ltd.	2002	—
*	K013461	Nlite System,Model A00-1025 Summary page 1 …10 Product Code: GEX Panel: 79 Predicate devices: ICN (and SLS BIOPHILE) NLite Laser Systems (K0008 11, K020729, K013461, K014130); Candela Vbeam (K021180), and Norseld Dual Yellow Laser (K023899); Asclepion-Meditec YelloStar(KO139…	Icn Photonics, Ltd.	2002	—
*	K014130	Nlite System Summary page 1 …Product Code: GEX Panel: 79 Predicate devices: ICN (and SLS BIOPHILE) NLite Laser Systems (K0008 11, K020729, K013461, K014130); Candela Vbeam (K021180), and Norseld Dual Yellow Laser (K023899); Asclepion-Meditec YelloStar(KO13940); COSM…	Icn Photonics, Ltd.	2002	—
*	K021180	Candela Vbeam Pulsed Dye Laser System Summary page 1 …: GEX Panel: 79 Predicate devices: ICN (and SLS BIOPHILE) NLite Laser Systems (K0008 11, K020729, K013461, K014130); Candela Vbeam (K021180), and Norseld Dual Yellow Laser (K023899); Asclepion-Meditec YelloStar(KO13940); COSMOS COM…	Candela Corp.	2002	—
*	K023899	Dual Yellow Laser, Model D10B Summary page 1 …nd SLS BIOPHILE) NLite Laser Systems (K0008 11, K020729, K013461, K014130); Candela Vbeam (K021180), and Norseld Dual Yellow Laser (K023899); Asclepion-Meditec YelloStar(KO13940); COSMOS COMPACT KTP (K983020); Dio-Light/DioLite (K981447, K980201,…	Norseld Pty., Ltd.	2003	—
*	K013940	Laser System Yellowstar	Asclepion-Meditec AG	2002	—
*	K983020	Compact KTP Laser Summary page 1 …14130); Candela Vbeam (K021180), and Norseld Dual Yellow Laser (K023899); Asclepion-Meditec YelloStar(KO13940); COSMOS COMPACT KTP (K983020); Dio-Light/DioLite (K981447, K980201, K964074); Laserscope Lyra (K990903); and Viridis Laser (KOO 1784).…	Cosmos Medical Technology	1998	—
*	K981447	Dio-Light 60 Laser System Summary page 1 …0), and Norseld Dual Yellow Laser (K023899); Asclepion-Meditec YelloStar(KO13940); COSMOS COMPACT KTP (K983020); Dio-Light/DioLite (K981447, K980201, K964074); Laserscope Lyra (K990903); and Viridis Laser (KOO 1784).…	Nidek, Inc.	1998	—
*	K980201	Dio-Light Laser System Summary page 1 …orseld Dual Yellow Laser (K023899); Asclepion-Meditec YelloStar(KO13940); COSMOS COMPACT KTP (K983020); Dio-Light/DioLite (K981447, K980201, K964074); Laserscope Lyra (K990903); and Viridis Laser (KOO 1784).…	Nidek, Inc.	1998	—
*	K964074	Diolite 532 Summary page 1 …Laser (K023899); Asclepion-Meditec YelloStar(KO13940); COSMOS COMPACT KTP (K983020); Dio-Light/DioLite (K981447, K980201, K964074); Laserscope Lyra (K990903); and Viridis Laser (KOO 1784).…	Iriderm Div.	1997	—
*	K990903	Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration) Summary page 1 …Asclepion-Meditec YelloStar(KO13940); COSMOS COMPACT KTP (K983020); Dio-Light/DioLite (K981447, K980201, K964074); Laserscope Lyra (K990903); and Viridis Laser (KOO 1784). 31.7 ==…	Laserscope	1999	—
*	K001784	Viridis Laser	Cosmos Medical Technology	2000	—

Also cleared against K000811: 6 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K132976	Advatx	Advalight Aps	2014	1

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?

The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
None of the 52 ancestors has a recall.
Of its descendants, K132976 (Advalight Aps, 2014) has gone furthest, with 1 descendant of its own.
6 other devices also cite its predicate K000811.

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 Dual Yellow laser, operating at 578 nm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous vascular lesions including but not limited to: Treatment of wrinkles, Periocular wrinkles, Periorbital wrinkles. Facial and leg telangiectasia, Rosacea, Cherry angiomas, Port wine stains, Hemangiomas and venous lakes, Angiorma, Spider angioma, and Poikiloderma of Civatte, Inflammatory Acne Vulgaris…

Read the full statement (125 words)

The Dual Yellow laser, operating at 578 nm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous vascular lesions including but not limited to:

Treatment of wrinkles,

Periocular wrinkles,

Periorbital wrinkles.

Facial and leg telangiectasia,

Rosacea,

Cherry angiomas,

Port wine stains,

Hemangiomas and venous lakes,

Angiorma,

Spider angioma, and

Poikiloderma of Civatte,

Inflammatory Acne Vulgaris,

Verrucae/Warts,

Scars,

Striea, and

Psoriasis.

Podiatry - for benign cutaneous lesions and warts.

The Dual Yellow lase, operating at 511 rm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous pigmented lesions including but not limited to:

Lentigines,

Solar keratoses,

Adenoma serabaceumn,

Skin tabs,

Trichoepitheliomas (benign lesions similar to skin tags)

Naevi,

Keratoses,

Syringornas

Seborrhoeic keratoses

Verrucae vulgaris, and

Warts.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032397 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032397: Dual Yellow Laser, Model Dual Yellow D10B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032397

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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