510(k) · Cleared

Cleared

Depilase Trio Lase Laser System

K030508510(k) TraditionalCleared May 20, 200390-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

Depilase Group, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on May 20, 2003 as substantially equivalent to K990718 (Laserscope, 2000) and 6 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1996.

Decided: May 20, 2003
Review: 90 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 7

Its longest line of descent runs back 5 generations to K963094 (1996). 23 ancestors in all, the oldest K950019 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
4 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
3 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
2 generations backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
1 generation backK984601 Candela Gentlelase II Dermatological LaserCandela Corp. · 1999
This deviceK030508 Depilase Trio Lase Laser SystemDepilase Group, Ltd. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K963094	Cynosure Photogenica LP Dermatological Vascular Lesion Laser	Cynosure, Inc.	1996	—
−4	K972767	Candela Gentlelase GL Dermatological Vascular Lesion Laser	Candela Corp.	1997	1
−3	K974381	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	—
−2	K981351	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	—
−1	K984601	Candela Gentlelase II Dermatological Laser	Candela Corp.	1999	—
0 (this device)	K030508	Depilase Trio Lase Laser System	Depilase Group, Ltd.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1997	5	0
1998	1	0
1999	2	0
2000	5	0
2001	2	0
2002	1	0

FIG. 1 — Lineage of K030508, 1996–2003Source: 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? (7)

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
*	K990718	Orion Series Surgical Laser System (SL Seriesq-Switched ND:Yag Configuration) Summary page 2 …Equivalence Depilase believes that its DEPILASE TRIO LASE Laser System system is substantially equivalent, regarding the Nd:YAG laser emission, to the Laserscope Lyra (K990718, K020021), and Altus Medical Aesthetic CoolGlide (K991798) Nd: YAG Lasers previously cleared for both the coagulation and hemosta…	Laserscope	2000	—
*	K020021	Lyra Surgical Laser System and Accessiories (ND:Yag Configuration) Summary page 2 …nce Depilase believes that its DEPILASE TRIO LASE Laser System system is substantially equivalent, regarding the Nd:YAG laser emission, to the Laserscope Lyra (K990718, K020021), and Altus Medical Aesthetic CoolGlide (K991798) Nd: YAG Lasers previously cleared for both the coagulation and hemostasis of va…	Laserscope	2002	—
*	K991798	Acme Medical Aesthetic ND:Yag Laser Summary page 2 …E Laser System system is substantially equivalent, regarding the Nd:YAG laser emission, to the Laserscope Lyra (K990718, K020021), and Altus Medical Aesthetic CoolGlide (K991798) Nd: YAG Lasers previously cleared for both the coagulation and hemostasis of vascular lesions, the removal and permanent reducti…	Altus Medical	2000	—
*	K011939	Fotona Dualis, Fotona Dualis Plus	Fotona D.D.	2001	—
*	K994260	Candela Gentlelase GL Dermatological Laser Summary page 2 …lis KTP (KO1 1939), previously cleared for the coagulation and haemostasis of vascular lesions and regarding the Alexandrite laser emission, to the Candela GenteLASE GL (K994260), GenteLASE I1 (K984601) and the Cynosure Apogee TSK (K992757) Alexandrite lasers, all previously cleared for the removal of unwa…	Candela Corp.	2000	—
*	K984601	Candela Gentlelase II Dermatological Laser Summary page 2 …iously cleared for the coagulation and haemostasis of vascular lesions and regarding the Alexandrite laser emission, to the Candela GenteLASE GL (K994260), GenteLASE I1 (K984601) and the Cynosure Apogee TSK (K992757) Alexandrite lasers, all previously cleared for the removal of unwanted hair in Fitzpatrick…	Candela Corp.	1999	—
*	K992757	Cynosure Apogee-TKS Dermatological Laser Summary page 2 …haemostasis of vascular lesions and regarding the Alexandrite laser emission, to the Candela GenteLASE GL (K994260), GenteLASE I1 (K984601) and the Cynosure Apogee TSK (K992757) Alexandrite lasers, all previously cleared for the removal of unwanted hair in Fitzpatrick skin types I - IV They therefore hav…	Cynosure, Inc.	2000	—

Also cleared against K990718: 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 7 years and passes through 3 companies; a new generation was cleared every 7 months on median.
1 of the 23 ancestors has a recall of any class.
5 other devices also cite its predicate K990718.

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 DEPILASE TRIO LASE Laser System is intended for the coagulation and haemostasis of vascular lesions (532 and 1064 nm), the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (755 and 1064 nm) and the dermatological applications for the non invasive treatment of facial wrinkles (1064 nm).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030508 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030508: Depilase Trio Lase Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030508

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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