510(k) · Cleared

Cleared

Duralite-GL

K041262510(k) TraditionalCleared Aug 13, 200494-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

Laser Scientific · GEX Powered Laser Surgical Instrument

Cleared on Aug 13, 2004 as substantially equivalent to K024371 (Candela Corp., 2003) and 4 other predicates after a 94-day review. Its family tree reaches back 6 generations to 1996.

Decided: Aug 13, 2004
Review: 94 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 6

Its longest line of descent runs back 6 generations to K963094 (1996). 18 ancestors in all, the oldest K950019 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 6 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
5 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
4 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
3 generations backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
2 generations backK994260 Candela Gentlelase GL Dermatological LaserCandela Corp. · 2000
1 generation backK024335 Candela Gentlelase Family of Laser SystemsCandela Corp. · 2003 · Recalled
This deviceK041262 Duralite-GLLaser Scientific · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K963094	Cynosure Photogenica LP Dermatological Vascular Lesion Laser	Cynosure, Inc.	1996	—
−5	K972767	Candela Gentlelase GL Dermatological Vascular Lesion Laser	Candela Corp.	1997	1
−4	K974381	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	—
−3	K981351	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	—
−2	K994260	Candela Gentlelase GL Dermatological Laser	Candela Corp.	2000	—
−1	K024335	Candela Gentlelase Family of Laser Systems	Candela Corp.	2003	1
0 (this device)	K041262	Duralite-GL	Laser Scientific	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1997	4	0
1998	1	0
1999	2	0
2001	1	0
2003	2	0

FIG. 1 — Lineage of K041262, 1996–2004Source: 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? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K024371	Candela Gentle Lase Family of Laser System Summary page 1 …al, Powered, laser 79-GEX, 21 CFR 878-48 Legally Marketed Predicate Device: GentleLASE Plus Fiber Optic cleared under K024371, K024260, K024335, K994260, K98460 IK003460 Description of the DuraLITE-GL…	Candela Corp.	2003	—
*	K024260	Candela Gentlelase Family of Laser Systems Summary page 1 …ed, laser 79-GEX, 21 CFR 878-48 Legally Marketed Predicate Device: GentleLASE Plus Fiber Optic cleared under K024371, K024260, K024335, K994260, K98460 IK003460 Description of the DuraLITE-GL The Du…	Candela Corp.	2003	1
*	K024335	Candela Gentlelase Family of Laser Systems Summary page 1 …79-GEX, 21 CFR 878-48 Legally Marketed Predicate Device: GentleLASE Plus Fiber Optic cleared under K024371, K024260, K024335, K994260, K98460 IK003460 Description of the DuraLITE-GL The DuraLITE-GL is an exact replacament campoatxt for the…	Candela Corp.	2003	1
*	K994260	Candela Gentlelase GL Dermatological Laser Summary page 1 …21 CFR 878-48 Legally Marketed Predicate Device: GentleLASE Plus Fiber Optic cleared under K024371, K024260, K024335, K994260, K98460 IK003460 Description of the DuraLITE-GL The DuraLITE-GL is an exact replacament campoatxt for the…	Candela Corp.	2000	—
Kept off the family tree	K984606	GentleLASE Plus Fiber Optic Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
*	K003460	Palomar Clear Light ND: Yag Laser System Summary page 1 …gally Marketed Predicate Device: GentleLASE Plus Fiber Optic cleared under K024371, K024260, K024335, K994260, K98460 IK003460 Description of the DuraLITE-GL The DuraLITE-GL is an exact replacament campoatxt for the…	Palomar Medical Technologies, Inc.	2001	—

Also cleared against K024371: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 8 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
3 of the 18 ancestors have a recall of any class.
5 other devices also cite its predicate K024371.

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 DuraLite-GL Is a mplacement fiber optic component for the Candela GeirnleLASE family of lasers.

The DuraLltsGL may be used as a replacement part for all procedures as cleared by the FDA for the Candela GentleLase family of lasers.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041262 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041262: Duralite-GL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041262

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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