510(k) · Cleared
ClearedAndela Dynamic Cooling Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Candela Laser Corp. · IMD Pack, Hot Or Cold, Disposable
Cleared on Aug 15, 1996 after a 528-day review. The FDA summary names its predicate without a number. 1,265 later devices descend from it.
- Decided
- Aug 15, 1996
- Review
- 528 days
- Class
- Class I
- Product code
- IMD
- Recalls
- None
- Predicates
- 0
1,265 later devices descend from it, 5 citing it directly.
- This deviceK951033 Andela Dynamic Cooling DeviceCandela Laser Corp. · 1996
- Descendant · cites it directly · 1,069 of its ownK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- Descendant · cites it directly · 1,064 of its ownK001589 Candela Dynamic Cooling DeviceCandela Corp. · 2000
- Descendant · cites it directly · 1,062 of its ownK990417 DermacoolOptomed Corp. · 1999
- 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
Showing 5 of 1,265 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,265 · See all- K000944Thermage Thermacool SystemThermage, Inc. · 2000 · cites it directly1,069descendants
- K001589Candela Dynamic Cooling DeviceCandela Corp. · 2000 · cites it directly1,064descendants
- K990417DermacoolOptomed Corp. · 1999 · cites it directly1,062descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951033 | Andela Dynamic Cooling Device | Candela Laser Corp. | 1996 | — |
| +1 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| +1 | K001589 | Candela Dynamic Cooling Device | Candela Corp. | 2000 | — |
| +1 | K990417 | Dermacool | Optomed Corp. | 1999 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 7 | 0 |
| 2003 | 17 | 0 |
| 2004 | 13 | 0 |
| 2005 | 23 | 0 |
| 2006 | 27 | 0 |
| 2007 | 34 | 0 |
| 2008 | 46 | 0 |
| 2009 | 38 | 0 |
| 2010 | 33 | 0 |
| 2011 | 30 | 0 |
| 2012 | 27 | 0 |
| 2013 | 46 | 0 |
| 2014 | 44 | 0 |
| 2015 | 46 | 0 |
| 2016 | 62 | 0 |
| 2017 | 64 | 0 |
| 2018 | 52 | 0 |
| 2019 | 45 | 0 |
| 2020 | 60 | 0 |
| 2021 | 62 | 0 |
| 2022 | 88 | 0 |
| 2023 | 77 | 0 |
| 2024 | 103 | 0 |
| 2025 | 136 | 0 |
| 2026 | 81 | 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 IMD? 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 IMD device
- #1 K221653 InfaTherm Disposable Infant Warming Mattressscore 4.4 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | — | Cool Laser Optics Device Named without a submission number | |
| * | — | Cold Packs Named without a submission number |
What descends from it? (1,265)
See all 1,2655 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K000944 | Thermage Thermacool System | 2000 | 1,069 |
| K001589 | Candela Dynamic Cooling Device | 2000 | 1,064 |
| K990417 | Dermacool | 1999 | 1,062 |
| K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | 2002 | 1,046 |
| K021650 | Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser | 2002 | 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?
- Of its descendants, K000944 (Thermage, Inc., 2000) has gone furthest, with 1,069 descendants of its own.
How does its category compare?
All IMD devicesIMD Pack, Hot Or Cold, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IMD
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · IMD
Too few IMD 510(k)s in any year since 2007 to give a median.
Recalls per year · IMD
4in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMD
66in 2025
MAUDE reports naming product code IMD, 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 | 1 | — | 0 | 211 |
| 2008 | 1 | — | 4 | 804 |
| 2009 | 0 | — | 0 | 210 |
| 2010 | 0 | — | 1 | 58 |
| 2011 | 0 | — | 0 | 70 |
| 2012 | 1 | — | 0 | 53 |
| 2013 | 0 | — | 0 | 40 |
| 2014 | 0 | — | 0 | 33 |
| 2015 | 0 | — | 1 | 193 |
| 2016 | 0 | — | 0 | 213 |
| 2017 | 1 | — | 0 | 234 |
| 2018 | 0 | — | 3 | 262 |
| 2019 | 0 | — | 0 | 632 |
| 2020 | 0 | — | 0 | 248 |
| 2021 | 0 | — | 4 | 142 |
| 2022 | 1 | — | 0 | 202 |
| 2023 | 0 | — | 0 | 184 |
| 2024 | 0 | — | 0 | 112 |
| 2025 | 0 | — | 0 | 66 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the Candela Dynamic Cooling Device is to minimize thermal injury to non-vascular skin structures during laser therapy of benign cutaneous vascular lesions, and to reduce pain associated with 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/K951033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951033: Andela Dynamic Cooling Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951033
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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