510(k) · Cleared
ClearedCandela Gentlelase II Dermatological Laser
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 Feb 4, 1999 as substantially equivalent to K981351 (Candela Corp., 1998) and 4 other predicates after a 38-day review. Its family tree reaches back 4 generations to 1996. 110 later devices descend from it.
- Decided
- Feb 4, 1999
- Review
- 38 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K963094 (1996). 7 ancestors in all. 110 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 3 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
- 2 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 1 generation backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- This deviceK984601 Candela Gentlelase II Dermatological LaserCandela Corp. · 1999
- Descendant · cites it directly · 106 of its ownK020412 Depilase Twin Lase Laser SystemDepilase Group, Ltd. · 2002
- Descendant · cites it directly · 104 of its ownK032218 Adept 1064/532/755 LaserAdept Medical Concepts · 2003
- Descendant · 2 generations on · 96 of its ownK083207 Ultrawave Iii EX 1320Quanta System Spa · 2008 · Recalled
- Descendant · 3 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- Descendant · 3 generations on · 40 of its ownK123168 Q-Plus T+ Ipl Laser SystemQuanta System Spa · 2012 · Recalled
Showing 5 of 110 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 110 · See all- K020412Depilase Twin Lase Laser SystemDepilase Group, Ltd. · 2002 · cites it directly106descendants
- K032218Adept 1064/532/755 LaserAdept Medical Concepts · 2003 · cites it directly104descendants
- K083207Ultrawave Iii EX 1320Quanta System Spa · 2008 · 2 generations on96descendants
- K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · 3 generations on57descendants
- K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa · 2012 · 3 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −3 | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser | Candela Corp. | 1997 | 1 |
| −2 | K974381 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −1 | K981351 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| 0 (this device) | K984601 | Candela Gentlelase II Dermatological Laser | Candela Corp. | 1999 | — |
| +1 | K020412 | Depilase Twin Lase Laser System | Depilase Group, Ltd. | 2002 | — |
| +1 | K032218 | Adept 1064/532/755 Laser | Adept Medical Concepts | 2003 | — |
| +2 | K083207 | Ultrawave Iii EX 1320 | Quanta System Spa | 2008 | 1 |
| +3 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| +3 | K123168 | Q-Plus T+ Ipl Laser System | Quanta System Spa | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 10 | 0 |
| 2021 | 3 | 0 |
| 2022 | 16 | 0 |
| 2023 | 7 | 0 |
| 2024 | 12 | 0 |
| 2025 | 14 | 0 |
| 2026 | 12 | 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? (5)
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 |
|---|---|---|---|
| * | K981351 | Candela Gentlelase GL Dermatological LaserSummary page 1…d Plastic Surgery and in Dermatology) Common Name: Dermatology Laser, Long pulse Alexandrite Laser Predicate Devices: Candela GentleLase GL laser cleared under 510(k)s K981351, K972767 and K974381, Sharplan EpiTouch Alex Laser cleared under 510(k) K973354 and the Cynosure Apogee 40 Laser cleared under 5… | 1998 |
| * | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion LaserSummary page 1…Surgery and in Dermatology) Common Name: Dermatology Laser, Long pulse Alexandrite Laser Predicate Devices: Candela GentleLase GL laser cleared under 510(k)s K981351, K972767 and K974381, Sharplan EpiTouch Alex Laser cleared under 510(k) K973354 and the Cynosure Apogee 40 Laser cleared under 510(k) not… | 1997 |
| * | K974381 | Candela Gentlelase GL Dermatological LaserSummary page 1…in Dermatology) Common Name: Dermatology Laser, Long pulse Alexandrite Laser Predicate Devices: Candela GentleLase GL laser cleared under 510(k)s K981351, K972767 and K974381, Sharplan EpiTouch Alex Laser cleared under 510(k) K973354 and the Cynosure Apogee 40 Laser cleared under 510(k) notification num… | 1998 |
| * | K973354 | Sharplan Epitouch Alexandrite Laser System (5000)Summary page 1…Alexandrite Laser Predicate Devices: Candela GentleLase GL laser cleared under 510(k)s K981351, K972767 and K974381, Sharplan EpiTouch Alex Laser cleared under 510(k) K973354 and the Cynosure Apogee 40 Laser cleared under 510(k) notification number K971737 Description: The Candela GentleLase II Laser… | 1997 |
| * | K971737 | Cynosure Photogenica Lpir Dermatological LaserSummary page 1…10(k)s K981351, K972767 and K974381, Sharplan EpiTouch Alex Laser cleared under 510(k) K973354 and the Cynosure Apogee 40 Laser cleared under 510(k) notification number K971737 Description: The Candela GentleLase II Laser utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers… | 1997 |
What descends from it? (110)
See all 1106 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020412 | Depilase Twin Lase Laser System | 2002 | 106 |
| K032218 | Adept 1064/532/755 Laser | 2003 | 104 |
| K032221 | Adept 1064/755 Laser | 2003 | 0 |
| K030508 | Depilase Trio Lase Laser System | 2003 | 0 |
| K021650 | Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser | 2002 | 0 |
| K994116 | Laser System Mediostar H (with and Without Skin Cooling System) | 2000 | 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 2 companies; a new generation was cleared every 7 months on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K020412 (Depilase Group, Ltd., 2002) has gone furthest, with 106 descendants of its own.
- 4 other devices also cite its predicate K981351.
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?
The Candela GentleLase II Dermatology Laser is indicated for the following uses:
1. the photocoagulation of dermatological vascular lesions.
2. the removal of hair.
The Candela GentleLase II Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for:
1. the reduction of pain.
2. cooling of skin prior to laser treatment.
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/K984601 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984601: Candela Gentlelase II Dermatological Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984601
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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