510(k) · Cleared
Recalled · Class II · 2013Candela Gentlelase Family of Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Candela Corp. · GEX Powered Laser Surgical Instrument
Cleared on Mar 21, 2003 as substantially equivalent to K994260 (Candela Corp., 2000) after an 88-day review. Its family tree reaches back 5 generations to 1996. 186 later devices descend from it. It has been recalled once.
- Decided
- Mar 21, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K963094 (1996). 14 ancestors in all, the oldest K950019 (1995). 186 later devices descend from it, 6 citing it directly.
- 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 backK994260 Candela Gentlelase GL Dermatological LaserCandela Corp. · 2000
- This deviceK024260 Candela Gentlelase Family of Laser SystemsCandela Corp. · 2003
- Descendant · cites it directly · 179 of its ownK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- Descendant · cites it directly · 114 of its ownK042474 ARIONWavelight Laser Technologie AG · 2004
- Descendant · 2 generations on · 113 of its ownK073534 Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2008
- Descendant · cites it directly · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
- Descendant · 2 generations on · 112 of its ownK081324 Candela Family of Q-Switched Alexandrite LasersCandela Corp. · 2008
Showing 5 of 186 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 186 · See all- K063074Candela 3630 Laser SystemCandela Corp. · 2006 · cites it directly179descendants
- K042474ARIONWavelight Laser Technologie AG · 2004 · cites it directly114descendants
- K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2008 · 2 generations on113descendants
- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · cites it directly112descendants
- K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp. · 2008 · 2 generations on112descendants
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 | K994260 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 2000 | — |
| 0 (this device) | K024260 | Candela Gentlelase Family of Laser Systems | Candela Corp. | 2003 | — |
| +1 | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| +1 | K042474 | ARION | Wavelight Laser Technologie AG | 2004 | — |
| +2 | K073534 | Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems | Candela Corp. | 2008 | — |
| +1 | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
| +2 | K081324 | Candela Family of Q-Switched Alexandrite Lasers | Candela Corp. | 2008 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 7 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 7 | 0 |
| 2018 | 13 | 0 |
| 2019 | 8 | 0 |
| 2020 | 17 | 0 |
| 2021 | 11 | 0 |
| 2022 | 22 | 0 |
| 2023 | 15 | 0 |
| 2024 | 20 | 0 |
| 2025 | 22 | 0 |
| 2026 | 13 | 0 |
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
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K994260 | Candela Gentlelase GL Dermatological LaserSummary page 1…in Dermatology) Common Name: Dermatology Laser, GentleLASE Family of Laser Systems Predicate Devices: Candela GentleLASE GL (K994260) Descrietion: The Candela GentleLASE Family of Lasers utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755… | 2000 |
What descends from it? (186)
See all 1866 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K063074 (Candela Corp., 2006) has gone furthest, with 179 descendants of its own.
- 10 other devices also cite its predicate K994260.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 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?
1. Temporary hair reduction.
2. Stable long-term, or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime.
3. On all skin types (Fitzpatrick I-VI) including tanned skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024260 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024260: Candela Gentlelase Family of Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024260
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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