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 Dec 3, 2003 as substantially equivalent to K022884 (Candela Corp., 2003) after a 261-day review. Its family tree reaches back 3 generations to 2000. 603 later devices descend from it. It has been recalled once.
- Decided
- Dec 3, 2003
- Review
- 261 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002421 (2000). 4 ancestors in all. 603 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002421 Candela Mid IR Diode Laser SystemCandela Corp. · 2000
- 2 generations backK013825 Candela Smoothbeam Laser SystemCandela Corp. · 2002 · Recalled
- 1 generation backK022884 Candela Smoothbeam Laser SystemCandela Corp. · 2003 · Recalled
- This deviceK030834 Candela Smoothbeam Laser SystemCandela Corp. · 2003
- Descendant · cites it directly · 569 of its ownK040131 Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemNew Star Lasers, Inc. · 2004
- Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · 3 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · cites it directly · 229 of its ownK041242 Candela Smoothbeam Laser SystemCandela Corp. · 2004
- Descendant · 3 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Showing 5 of 603 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 603 · See all- K040131Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser SystemNew Star Lasers, Inc. · 2004 · cites it directly569descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 3 generations on266descendants
- K041242Candela Smoothbeam Laser SystemCandela Corp. · 2004 · cites it directly229descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 3 generations on221descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002421 | Candela Mid IR Diode Laser System | Candela Corp. | 2000 | — |
| −2 | K013825 | Candela Smoothbeam Laser System | Candela Corp. | 2002 | 1 |
| −1 | K022884 | Candela Smoothbeam Laser System | Candela Corp. | 2003 | 1 |
| 0 (this device) | K030834 | Candela Smoothbeam Laser System | Candela Corp. | 2003 | — |
| +1 | K040131 | Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System | New Star Lasers, Inc. | 2004 | — |
| +2 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +3 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +1 | K041242 | Candela Smoothbeam Laser System | Candela Corp. | 2004 | — |
| +3 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
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 |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 11 | 0 |
| 2008 | 21 | 0 |
| 2009 | 10 | 0 |
| 2010 | 17 | 0 |
| 2011 | 18 | 0 |
| 2012 | 17 | 0 |
| 2013 | 18 | 0 |
| 2014 | 25 | 0 |
| 2015 | 24 | 0 |
| 2016 | 36 | 0 |
| 2017 | 27 | 0 |
| 2018 | 29 | 0 |
| 2019 | 18 | 0 |
| 2020 | 35 | 0 |
| 2021 | 30 | 0 |
| 2022 | 49 | 0 |
| 2023 | 37 | 0 |
| 2024 | 64 | 0 |
| 2025 | 68 | 0 |
| 2026 | 41 | 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 |
|---|---|---|---|
| * | K022884 | Candela Smoothbeam Laser SystemSummary page 1…gy) Common Name: Dermatology Laser, Smoothbeam Laser System Predicate Devices: Candela Smoothbeam 1450 nm Diode Laser System (K022884) Description: The Diode laser -is a Continuous Wave, diode medical laser, controlled by an embedded processor, to be used for u… | 2003 |
What descends from it? (603)
See all 6032 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 11 months on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K040131 (New Star Lasers, Inc., 2004) has gone furthest, with 569 descendants of its own.
- 3 other devices also cite its predicate K022884.
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 mild to moderate inflammatory acne vulgaris.
The intended use of the Candela Dynamic Cooling Device is:
Cooling of the skin prior to laser treatment
Reduction of pain during laser treatment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030834 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030834: Candela Smoothbeam Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030834
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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