510(k) · Cleared
ClearedCandela Dynamic Cooling Device
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 Aug 18, 2000 as substantially equivalent to K951033 (Candela Laser Corp., 1996) and 1 other predicate after an 87-day review. Its family tree reaches back 3 generations to 1991. 1,064 later devices descend from it.
- Decided
- Aug 18, 2000
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K904627 (1991). 21 ancestors in all. 1,064 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
- 2 generations backK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
- 1 generation backK972347 Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc. · 1997
- This deviceK001589 Candela Dynamic Cooling DeviceCandela Corp. · 2000
- Descendant · cites it directly · 1,046 of its ownK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
- Descendant · 2 generations on · 856 of its ownK030527 Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003
- Descendant · 2 generations on · 756 of its ownK030342 Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · Recalled
- Descendant · 2 generations on · 756 of its ownK024093 Modified Lumenis Family of Intense Pulsed-Light (Ipl) and…Lumenis, Ltd. · 2003
- Descendant · 3 generations on · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
Showing 5 of 1,064 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,064 · See all- K020839Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002 · cites it directly1,046descendants
- K030527Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsLumenis · 2003 · 2 generations on856descendants
- K030342Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag SystemsLumenis, Ltd. · 2003 · 2 generations on756descendants
- K024093Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl Systems and…Lumenis, Ltd. · 2003 · 2 generations on756descendants
- K033946Lovely SystemMsq (M2), Ltd. · 2004 · 3 generations on737descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904627 | Centauri Yag Laser Syst, Ear, Nose , Throat | Pfizer Laser Systems | 1991 | — |
| −2 | K960032 | Coherent Versapulse Aesthetic Surgical Lasers | Coherent Medical Group | 1996 | — |
| −1 | K972347 | Modified Coherent Versapulse Aesthetic Surgical Laser | Lumenis, Inc. | 1997 | — |
| 0 (this device) | K001589 | Candela Dynamic Cooling Device | Candela Corp. | 2000 | — |
| +1 | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | Lumenis, Inc. | 2002 | — |
| +2 | K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems | Lumenis | 2003 | — |
| +2 | K030342 | Lumenis Family of Ipl Systems and Combination Ipl/ND:Yag Systems | Lumenis, Ltd. | 2003 | 1 |
| +2 | K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl… | Lumenis, Ltd. | 2003 | — |
| +3 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 16 | 0 |
| 2006 | 23 | 0 |
| 2007 | 26 | 0 |
| 2008 | 41 | 0 |
| 2009 | 27 | 0 |
| 2010 | 27 | 0 |
| 2011 | 26 | 0 |
| 2012 | 22 | 0 |
| 2013 | 35 | 0 |
| 2014 | 37 | 0 |
| 2015 | 41 | 0 |
| 2016 | 50 | 0 |
| 2017 | 53 | 0 |
| 2018 | 45 | 0 |
| 2019 | 37 | 0 |
| 2020 | 53 | 0 |
| 2021 | 49 | 0 |
| 2022 | 78 | 0 |
| 2023 | 65 | 0 |
| 2024 | 93 | 0 |
| 2025 | 127 | 0 |
| 2026 | 75 | 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 |
|---|---|---|---|
| * | K951033 | Andela Dynamic Cooling DeviceSummary page 1…a Dynamic Cooling Device, which is substantially equivalent to previously marketed devices intended for cooling of the skin and reduction of pain during taser treatmeat (K951033) and for protecting the dermis from thermal injury, which reduces possible side effects such as scabbing, scarring, and hyperpigm… | 1996 |
| * | K972347 | Modified Coherent Versapulse Aesthetic Surgical LaserSummary page 1…uring taser treatmeat (K951033) and for protecting the dermis from thermal injury, which reduces possible side effects such as scabbing, scarring, and hyperpigmentation (K972347) and allows for the utilization of higher laver fluences for laser treatment. ' Submitted by: Candela Corporation 530 Boston Pos… | 1997 |
What descends from it? (1,064)
See all 1,0644 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 9 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- None of the 21 ancestors has a recall.
- Of its descendants, K020839 (Lumenis, Inc., 2002) has gone furthest, with 1,046 descendants of its own.
- 4 other devices also cite its predicate K951033.
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 intended use of the Candela Dynamic Cooling Device is:
(1) cooling of the skin prior to laser treatment
(2) reduction of pain during laser treatment
(3) allows for use of higher laser fluences for laser treatments, such as for hair removal and vascular lesions
(4) reduces potential side effects of laser treatments, such as for hair removal and vascular lesions
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/K001589 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001589: Candela Dynamic Cooling Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001589
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026