510(k) · Cleared
ClearedCandela Gentlelase GL 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 10, 1998 as substantially equivalent to K972767 (Candela Corp., 1997) after an 82-day review. Its family tree reaches back 2 generations to 1996. 1,178 later devices descend from it.
- Decided
- Feb 10, 1998
- Review
- 82 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963094 (1996). 1,178 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 1 generation backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
- This deviceK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- Descendant · cites it directly · 1,062 of its ownK990417 DermacoolOptomed Corp. · 1999
- Descendant · 2 generations on · 1,046 of its ownK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
- Descendant · 3 generations on · 856 of its ownK030527 Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003
- Descendant · cites it directly · 811 of its ownK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- Descendant · 3 generations on · 756 of its ownK030342 Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · Recalled
Showing 5 of 1,178 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,178 · See all- K990417DermacoolOptomed Corp. · 1999 · cites it directly1,062descendants
- K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002 · 2 generations on1,046descendants
- K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003 · 3 generations on856descendants
- K981351Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998 · cites it directly811descendants
- K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · 3 generations on756descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −1 | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser | Candela Corp. | 1997 | 1 |
| 0 (this device) | K974381 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| +1 | K990417 | Dermacool | Optomed Corp. | 1999 | — |
| +2 | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | Lumenis, Inc. | 2002 | — |
| +3 | K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems | Lumenis | 2003 | — |
| +1 | K981351 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| +3 | K030342 | Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems | Lumenis, Ltd. | 2003 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 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 |
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? (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 | Decided |
|---|---|---|---|
| * | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser Cleared while this submission was under review Summary page 1…and Plastic Surgery and in Dermatology) Common Name: Dermatology Laser, Long pulse Alexandrite Laser Predicate Device: Candela Gentlelase GL laser cleared under 510(k) 972767. The Candela (Modified) Gentlelase GL Laser utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in… | 1997 |
| * | — | Candela Dynamic Cooling Device Named without a submission number |
What descends from it? (1,178)
See all 1,1785 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)
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 2 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K990417 (Optomed Corp., 1999) has gone furthest, with 1,062 descendants of its own.
- 2 other devices also cite its predicate K972767.
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 GL Dermatology Laser is indicated for the following uses:
1. the photocoagulation of dermatological vascular lesions.
The Candela GentleLase GL 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/K974381 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974381: Candela Gentlelase GL Dermatological Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974381
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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