510(k) · Cleared
ClearedCandela Gentlelase Family of Lasers
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 Jul 18, 2011 as substantially equivalent to K024371 (Candela Corp., 2003) and 6 other predicates after an 87-day review. Its family tree reaches back 6 generations to 1996. 91 later devices descend from it.
- Decided
- Jul 18, 2011
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K963094 (1996). 17 ancestors in all, the oldest K950019 (1995). 91 later devices descend from it, 1 citing it directly.
- 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 deviceK111144 Candela Gentlelase Family of LasersCandela Corp. · 2011
- Descendant · cites it directly · 90 of its ownK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- Descendant · 2 generations on · 36 of its ownK132185 Family of Coolglide Aesthetic LasersCutera, Inc. · 2013
- Descendant · 3 generations on · 32 of its ownK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
- Descendant · 3 generations on · 24 of its ownK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
- Descendant · 2 generations on · 24 of its ownK133319 ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd. · 2014
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K112715Candela Gentlemax Family of LasersCandela Corp. · 2011 · cites it directly90descendants
- K132185Family of Coolglide Aesthetic LasersCutera, Inc. · 2013 · 2 generations on36descendants
- K153671Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016 · 3 generations on32descendants
- K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc. · 2017 · 3 generations on24descendants
- K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd. · 2014 · 2 generations on24descendants
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) | K111144 | Candela Gentlelase Family of Lasers | Candela Corp. | 2011 | — |
| +1 | K112715 | Candela Gentlemax Family of Lasers | Candela Corp. | 2011 | — |
| +2 | K132185 | Family of Coolglide Aesthetic Lasers | Cutera, Inc. | 2013 | — |
| +3 | K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016 | — |
| +3 | K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology… | Alma Lasers, Inc. | 2017 | — |
| +2 | K133319 | ET Lightsheer 1060, High Speed Lightsheer 1060 | Lumenis, Ltd. | 2014 | — |
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 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 7 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 11 | 0 |
| 2023 | 11 | 0 |
| 2024 | 12 | 0 |
| 2025 | 9 | 0 |
| 2026 | 7 | 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? (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 | Decided |
|---|---|---|---|
| * | K024371 | Candela Gentle Lase Family of Laser SystemSummary page 1…Dermatology Laser, GentleL-ASE Family of Laser Systems Predicate Devices: GentleL-ASE Family of Laser Systems (K024371, K024335, K024260) Candela GentleLASE GL and previous Candela GentleLASE… | 2003 |
| * | K024335 | Candela Gentlelase Family of Laser SystemsSummary page 1…ogy Laser, GentleL-ASE Family of Laser Systems Predicate Devices: GentleL-ASE Family of Laser Systems (K024371, K024335, K024260) Candela GentleLASE GL and previous Candela GentleLASE… | 2003 |
| * | K024260 | Candela Gentlelase Family of Laser SystemsSummary page 1…, GentleL-ASE Family of Laser Systems Predicate Devices: GentleL-ASE Family of Laser Systems (K024371, K024335, K024260) Candela GentleLASE GL and previous Candela GentleLASE… | 2003 |
| * | K994260 | Candela Gentlelase GL Dermatological LaserSummary page 1…(K024371, K024335, K024260) Candela GentleLASE GL and previous Candela GentleLASE models (K994260, K981351, K974381, K972767) Description: The Candela GentleL-ASE Family of Lasers utilizes an Alexandrite rod (crystal) which em… | 2000 |
| * | K981351 | Candela Gentlelase GL Dermatological LaserSummary page 1…371, K024335, K024260) Candela GentleLASE GL and previous Candela GentleLASE models (K994260, K981351, K974381, K972767) Description: The Candela GentleL-ASE Family of Lasers utilizes an Alexandrite rod (crystal) which emits pulse… | 1998 |
| * | K974381 | Candela Gentlelase GL Dermatological LaserSummary page 1…335, K024260) Candela GentleLASE GL and previous Candela GentleLASE models (K994260, K981351, K974381, K972767) Description: The Candela GentleL-ASE Family of Lasers utilizes an Alexandrite rod (crystal) which emits pulsed energy… | 1998 |
| * | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion LaserSummary page 1…260) Candela GentleLASE GL and previous Candela GentleLASE models (K994260, K981351, K974381, K972767) Description: The Candela GentleL-ASE Family of Lasers utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 na… | 1997 |
What descends from it? (91)
See all 911 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112715 | Candela Gentlemax Family of Lasers | 2011 | 90 |
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 15 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K112715 (Candela Corp., 2011) has gone furthest, with 90 descendants of its own.
- 5 other devices also cite its predicate K024371.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111144: Candela Gentlelase Family of Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111144
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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