510(k) · Cleared
ClearedCandela Mid IR Diode Laser System
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 Nov 3, 2000 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 744 later devices descend from it.
- Decided
- Nov 3, 2000
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
744 later devices descend from it, 2 citing it directly.
- This deviceK002421 Candela Mid IR Diode Laser SystemCandela Corp. · 2000
- Descendant · cites it directly · 740 of its ownK013825 Candela Smoothbeam Laser SystemCandela Corp. · 2002 · Recalled
- Descendant · 2 generations on · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- Descendant · 2 generations on · 642 of its ownK022884 Candela Smoothbeam Laser SystemCandela Corp. · 2003 · Recalled
- Descendant · 3 generations on · 603 of its ownK030834 Candela Smoothbeam Laser SystemCandela Corp. · 2003 · Recalled
- Descendant · 4 generations on · 569 of its ownK040131 Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemNew Star Lasers, Inc. · 2004
Showing 5 of 744 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 744 · See all- K013825Candela Smoothbeam Laser SystemCandela Corp. · 2002 · cites it directly740descendants
- K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · 2 generations on665descendants
- K022884Candela Smoothbeam Laser SystemCandela Corp. · 2003 · 2 generations on642descendants
- K030834Candela Smoothbeam Laser SystemCandela Corp. · 2003 · 3 generations on603descendants
- K040131Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemNew Star Lasers, Inc. · 2004 · 4 generations on569descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002421 | Candela Mid IR Diode Laser System | Candela Corp. | 2000 | — |
| +1 | K013825 | Candela Smoothbeam Laser System | Candela Corp. | 2002 | 1 |
| +2 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| +2 | K022884 | Candela Smoothbeam Laser System | Candela Corp. | 2003 | 1 |
| +3 | K030834 | Candela Smoothbeam Laser System | Candela Corp. | 2003 | 1 |
| +4 | K040131 | Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System | New Star Lasers, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 11 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 16 | 0 |
| 2008 | 26 | 0 |
| 2009 | 15 | 0 |
| 2010 | 19 | 0 |
| 2011 | 24 | 0 |
| 2012 | 21 | 0 |
| 2013 | 27 | 0 |
| 2014 | 30 | 0 |
| 2015 | 27 | 0 |
| 2016 | 37 | 0 |
| 2017 | 33 | 0 |
| 2018 | 32 | 0 |
| 2019 | 23 | 0 |
| 2020 | 42 | 0 |
| 2021 | 32 | 0 |
| 2022 | 56 | 0 |
| 2023 | 44 | 0 |
| 2024 | 71 | 0 |
| 2025 | 86 | 0 |
| 2026 | 48 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (744)
See all 7442 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?
- Of its descendants, K013825 (Candela Corp., 2002) has gone furthest, with 740 descendants of its own.
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 | — |
https://510kreport.com/device/K002421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002421: Candela Mid IR Diode Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002421
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026