510(k) · Cleared

Cleared

15W Ceralas D 1470NM Diode Laser, Model D1470

K082225510(k) SpecialCleared Dec 3, 2008119-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

Biolitec, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Dec 3, 2008 as substantially equivalent to K043046 (New Star Lasers, Inc., 2005) and 3 other predicates after a 119-day review. Its family tree reaches back 1 generation to 2005. 128 later devices descend from it.

Decided: Dec 3, 2008
Review: 119 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K043046 (2005). 4 ancestors in all. 128 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK043046 Cooltouch, Model CT3SNew Star Lasers, Inc. · 2005
This deviceK082225 15W Ceralas D 1470NM Diode Laser, Model D1470Biolitec, Inc. · 2008
Descendant · cites it directly · 112 of its ownK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
Descendant · cites it directly · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Descendant · 2 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Descendant · 3 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
Descendant · 2 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014

Showing 5 of 128 descendants. See all descendants

Descendants cleared per year

2010high 18 (2022) · low 0 (2012)2026

Most influential descendants

Showing 5 of 128 · See all

K082230Vectra Plus Laser System and AccessoriesXintec Corporation · 2010 · cites it directly112descendants
K101916Joule Multi-Platform SystemSciton, Inc · 2011 · cites it directly111descendants
K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 2 generations on70descendants
K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 3 generations on62descendants
K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · 2 generations on57descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K043046	Cooltouch, Model CT3S	New Star Lasers, Inc.	2005	—
0 (this device)	K082225	15W Ceralas D 1470NM Diode Laser, Model D1470	Biolitec, Inc.	2008	—
+1	K082230	Vectra Plus Laser System and Accessories	Xintec Corporation	2010	—
+1	K101916	Joule Multi-Platform System	Sciton, Inc	2011	—
+2	K132806	Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece	Fotona D.D.	2014	—
+3	K143723	SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro	Fotona D.D.	2015	—
+2	K140009	Soprano Ice Multi-Application & Multi-Technology Platform	Alma Lasers, Ltd.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	3	0
2014	3	0
2015	6	0
2016	1	0
2017	5	0
2018	8	0
2019	6	0
2020	11	0
2021	9	0
2022	18	0
2023	10	0
2024	18	0
2025	18	0
2026	11	0

FIG. 1 — Lineage of K082225, 2005–2026Source: 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

Get a 510(k) Report

What was it cleared against? (5)

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
*	K043046	Cooltouch, Model CT3S Summary page 1 …Surgical Diode Laser System Predicate Devices Biolitec, Inc.'s 15W Ceralas D 1470nm Diode Laser (Model D1470) Cool Touch CTEV 1320 Nd:YAG Laser (K043046,K051434, K061618 and K062210) Purpose of the Special 510(k) notice. The Ceralas D1470 is a modification to Biolitec'…	New Star Lasers, Inc.	2005	—
*	K051434	Cooltouch ND:Yag Laser Systems, Models CT3S and Ctev Summary page 1 …l Diode Laser System Predicate Devices Biolitec, Inc.'s 15W Ceralas D 1470nm Diode Laser (Model D1470) Cool Touch CTEV 1320 Nd:YAG Laser (K043046,K051434, K061618 and K062210) Purpose of the Special 510(k) notice. The Ceralas D1470 is a modification to Biolitec's previo…	New Star Lasers, Inc.	2005	—
*	K061618	Cooltouch, Model Ctev Summary page 1 …aser System Predicate Devices Biolitec, Inc.'s 15W Ceralas D 1470nm Diode Laser (Model D1470) Cool Touch CTEV 1320 Nd:YAG Laser (K043046,K051434, K061618 and K062210) Purpose of the Special 510(k) notice. The Ceralas D1470 is a modification to Biolitec's previously clea…	New Star Lasers, Inc.	2006	—
*	K062210	Cool Touch, Models CT3S, Ctev, NS160, Ctev, LC160 Summary page 1 …Predicate Devices Biolitec, Inc.'s 15W Ceralas D 1470nm Diode Laser (Model D1470) Cool Touch CTEV 1320 Nd:YAG Laser (K043046,K051434, K061618 and K062210) Purpose of the Special 510(k) notice. The Ceralas D1470 is a modification to Biolitec's previously cleared Ceralas…	New Star Lasers, Inc.	2006	—
*	—	Biolitec, Inc.'s 15W Ceralas D 1470nm Diode Laser (Model D1470) Named without a submission number			—

Also cleared against K043046: 3 other devices →

What descends from it? (128)

See all 128

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

Number	Device	Applicant	Decided	Descendants
K082230	Vectra Plus Laser System and Accessories	Xintec Corporation	2010	112
K101916	Joule Multi-Platform System	Sciton, Inc	2011	111
K112253	Ceralas 147NM Diode Laser System	Biolitec, Inc.	2011	18
K160549	Medical Diode Laser Systems	Wuhan Gigaa Optronics Technology Co., Ltd.	2017	6
K110225	Angiodynamics, Inc. Venacure 1470 Laser	AngioDynamics, Inc.	2011	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?

None of the 4 ancestors has a recall.
Of its descendants, K082230 (Xintec Corporation, 2010) has gone furthest, with 112 descendants of its own.
3 other devices also cite its predicate K043046.

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. 2008, this device’s year, is highlighted.

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 Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082225 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082225: 15W Ceralas D 1470NM Diode Laser, Model D1470.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082225

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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