510(k) · Cleared
Recalled · 2003Candela Smoothbeam 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 Jan 22, 2003 as substantially equivalent to K013825 (Candela Corp., 2002) after a 145-day review. Its family tree reaches back 2 generations to 2000. 642 later devices descend from it. It has been recalled once.
- Decided
- Jan 22, 2003
- Review
- 145 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002421 (2000). 3 ancestors in all. 642 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK002421 Candela Mid IR Diode Laser SystemCandela Corp. · 2000
- 1 generation backK013825 Candela Smoothbeam Laser SystemCandela Corp. · 2002 · Recalled
- This deviceK022884 Candela Smoothbeam Laser SystemCandela Corp. · 2003
- Descendant · cites it directly · 603 of its ownK030834 Candela Smoothbeam Laser SystemCandela Corp. · 2003 · Recalled
- Descendant · 2 generations on · 569 of its ownK040131 Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemNew Star Lasers, Inc. · 2004
- Descendant · cites it directly · 524 of its ownK030453 Cooltouch ND: Yag Laser SystemNew Star Lasers, Inc. · 2003
- Descendant · cites it directly · 518 of its ownK032459 Profile 1320 Laser SystemSciton, Inc · 2004
- Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
Showing 5 of 642 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 642 · See all- K030834Candela Smoothbeam Laser SystemCandela Corp. · 2003 · cites it directly603descendants
- K040131Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemNew Star Lasers, Inc. · 2004 · 2 generations on569descendants
- K030453Cooltouch ND: Yag Laser SystemNew Star Lasers, Inc. · 2003 · cites it directly524descendants
- K032459Profile 1320 Laser SystemSciton, Inc · 2004 · cites it directly518descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002421 | Candela Mid IR Diode Laser System | Candela Corp. | 2000 | — |
| −1 | K013825 | Candela Smoothbeam Laser System | Candela Corp. | 2002 | 1 |
| 0 (this device) | K022884 | Candela Smoothbeam Laser System | Candela Corp. | 2003 | — |
| +1 | K030834 | Candela Smoothbeam Laser System | Candela Corp. | 2003 | 1 |
| +2 | K040131 | Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System | New Star Lasers, Inc. | 2004 | — |
| +1 | K030453 | Cooltouch ND: Yag Laser System | New Star Lasers, Inc. | 2003 | — |
| +1 | K032459 | Profile 1320 Laser System | Sciton, Inc | 2004 | — |
| +2 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 15 | 0 |
| 2008 | 23 | 0 |
| 2009 | 13 | 0 |
| 2010 | 18 | 0 |
| 2011 | 19 | 0 |
| 2012 | 18 | 0 |
| 2013 | 21 | 0 |
| 2014 | 26 | 0 |
| 2015 | 24 | 0 |
| 2016 | 36 | 0 |
| 2017 | 29 | 0 |
| 2018 | 29 | 0 |
| 2019 | 20 | 0 |
| 2020 | 36 | 0 |
| 2021 | 31 | 0 |
| 2022 | 52 | 0 |
| 2023 | 40 | 0 |
| 2024 | 65 | 0 |
| 2025 | 70 | 0 |
| 2026 | 42 | 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? (1)
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 |
|---|---|---|---|
| * | K013825 | Candela Smoothbeam Laser System | 2002 |
What descends from it? (642)
See all 6424 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2003 | Not classified | Z-0291-04 | Other | Laser may pulse and not dispense cryogen resulting in patient injury |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K030834 (Candela Corp., 2003) has gone furthest, with 603 descendants of its own.
- 4 other devices also cite its predicate K013825.
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 Smoothbeam Laser System is indicated for the treatment of Atrophic Acne Scars.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022884: Candela Smoothbeam 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/K022884
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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