510(k) · Cleared

Recalled · Class II · 2013

Candela Gentlelase GL Dermatological Vascular Lesion Laser

K972767510(k) TraditionalCleared Dec 4, 1997133-day reviewClass II21 CFR 878.4810Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Candela Corp. · GEX Powered Laser Surgical Instrument

Cleared on Dec 4, 1997 as substantially equivalent to K963094 (Cynosure, Inc., 1996) after a 133-day review. Its family tree reaches back 1 generation to 1996. 1,179 later devices descend from it. It has been recalled once.

Decided: Dec 4, 1997
Review: 133 days
Class: Class II
Product code: GEX
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K963094 (1996). 1,179 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
This deviceK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997
Descendant · cites it directly · 1,178 of its ownK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
Descendant · 2 generations on · 1,062 of its ownK990417 DermacoolOptomed Corp. · 1999
Descendant · 3 generations on · 1,046 of its ownK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
Descendant · 4 generations on · 856 of its ownK030527 Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003
Descendant · 2 generations on · 811 of its ownK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998

Showing 5 of 1,179 descendants. See all descendants

Descendants cleared per year

1998high 128 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 1,179 · See all

K974381Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998 · cites it directly1,178descendants
K990417DermacoolOptomed Corp. · 1999 · 2 generations on1,062descendants
K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002 · 3 generations on1,046descendants
K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003 · 4 generations on856descendants
K981351Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998 · 2 generations on811descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K963094	Cynosure Photogenica LP Dermatological Vascular Lesion Laser	Cynosure, Inc.	1996	—
0 (this device)	K972767	Candela Gentlelase GL Dermatological Vascular Lesion Laser	Candela Corp.	1997	—
+1	K974381	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	—
+2	K990417	Dermacool	Optomed Corp.	1999	—
+3	K020839	Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL	Lumenis, Inc.	2002	—
+4	K030527	Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems	Lumenis	2003	—
+2	K981351	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	2	0
2000	4	0
2002	10	0
2003	18	0
2004	16	0
2005	22	0
2006	25	0
2007	27	0
2008	46	0
2009	31	0
2010	30	0
2011	33	0
2012	29	0
2013	42	0
2014	43	0
2015	45	0
2016	54	0
2017	56	0
2018	49	0
2019	42	0
2020	55	0
2021	50	0
2022	82	0
2023	67	0
2024	94	0
2025	128	0
2026	77	0

FIG. 1 — Lineage of K972767, 1996–2026Source: 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? (2)

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
*	K963094	Cynosure Photogenica LP Dermatological Vascular Lesion Laser Summary page 1 …ology) Common Name: Dermatology Laser, Longpulse Alexandrite Laser Predicate Device: Cynosure Photogenica LP Laser cleared on 10/29/96 under 510(k) notification number K963094 The Candela Gentlelase GL Lasers utilize an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near in…	Cynosure, Inc.	1996	—
*	—	Candela Q-Switched Alexandrite Lasers Named without a submission number			—

Also cleared against K963094: 2 other devices →

What descends from it? (1,179)

See all 1,179

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

Number	Device	Applicant	Decided	Descendants
K974381	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	1,178
K984601	Candela Gentlelase II Dermatological Laser	Candela Corp.	1999	110
K111144	Candela Gentlelase Family of Lasers	Candela Corp.	2011	91

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 6, 2013	Class II	Z-0348-2014	Software design	Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K974381 (Candela Corp., 1998) has gone furthest, with 1,178 descendants of its own.
2 other devices also cite its predicate K963094.

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 Candela Gentlelase GL Dermatology Vascular Lesion Laser is used for the photocoagulation of dermatological vascular lesions.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K972767 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972767: Candela Gentlelase GL Dermatological Vascular Lesion Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972767

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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