510(k) · Cleared

Cleared

Candela Gentle Yag Laser System, Variable Pulse Yag

K022951510(k) TraditionalCleared Jan 27, 2003144-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

Candela Corp. · GEX Powered Laser Surgical Instrument

Cleared on Jan 27, 2003 as substantially equivalent to K010104 (Candela Corp., 2001) and 1 other predicate after a 144-day review. Its family tree reaches back 2 generations to 2000. 657 later devices descend from it.

Decided: Jan 27, 2003
Review: 144 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K000811 (2000). 4 ancestors in all. 657 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK000811 Nlite System, SLS Model Number A00-1025Sls Biophile, Ltd. · 2000
1 generation backK020021 Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)Laserscope · 2002
This deviceK022951 Candela Gentle Yag Laser System, Variable Pulse YagCandela Corp. · 2003
Descendant · cites it directly · 654 of its ownK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
Descendant · cites it directly · 519 of its ownK033251 The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
Descendant · 2 generations on · 316 of its ownK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
Descendant · 3 generations on · 284 of its ownK042319 Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005

Showing 5 of 657 descendants. See all descendants

Descendants cleared per year

2003high 69 (2025) · low 1 (2003)2026

Most influential descendants

Showing 5 of 657 · See all

K033172Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003 · cites it directly654descendants
K033251The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004 · cites it directly519descendants
K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
K040617Reliant Laser System IIReliant Technologies, Inc. · 2004 · 2 generations on316descendants
K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005 · 3 generations on284descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K000811	Nlite System, SLS Model Number A00-1025	Sls Biophile, Ltd.	2000	—
−1	K020021	Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)	Laserscope	2002	—
0 (this device)	K022951	Candela Gentle Yag Laser System, Variable Pulse Yag	Candela Corp.	2003	—
+1	K033172	Candela Gentleyag Family of Laser Systems	Candela Corp.	2003	—
+1	K033251	The Friendlylight ND: Yag Lasers	Innotech USA, Inc.	2004	—
+2	K042000	Modified MSQ Family of Lovely Light/Laser Systems	Msq (M2), Ltd.	2004	—
+2	K040617	Reliant Laser System II	Reliant Technologies, Inc.	2004	—
+3	K042319	Reliant Laser II System and Accessories	Reliant Technologies, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	3	0
2005	4	0
2006	5	0
2007	15	0
2008	23	0
2009	14	0
2010	18	0
2011	20	0
2012	19	0
2013	23	0
2014	30	0
2015	24	0
2016	38	0
2017	30	0
2018	30	0
2019	22	0
2020	38	0
2021	31	0
2022	52	0
2023	40	0
2024	66	0
2025	69	0
2026	42	0

FIG. 1 — Lineage of K022951, 2000–2026Source: 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
*	K010104	Candela Long Pulse ND:Yag	Candela Corp.	2001	—
*	K020021	Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)	Laserscope	2002	—

Also cleared against K010104: 5 other devices →

What descends from it? (657)

See all 657

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

Number	Device	Applicant	Decided	Descendants
K033172	Candela Gentleyag Family of Laser Systems	Candela Corp.	2003	654
K033251	The Friendlylight ND: Yag Lasers	Innotech USA, Inc.	2004	519
K132286	Hyperion Long Pulsed ND: Yag Laser	Scarlet Rf, Inc.	2014	3
K051876	Multiwave XR	Pacific Quantum Instruments, Inc.	2005	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?

The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K033172 (Candela Corp., 2003) has gone furthest, with 654 descendants of its own.
5 other devices also cite its predicate K010104.

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 GentleYAG Laser System is intended for the treatment of facial wrinkles.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022951 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022951: Candela Gentle Yag Laser System, Variable Pulse Yag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022951

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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