510(k) · Cleared
ClearedCandela Q-Switched Alexandrite Lasers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Candela Laser Corp. · GEX Powered Laser Surgical Instrument
Cleared on Jun 14, 1996 after a 185-day review. The FDA summary names its predicate without a number. 118 later devices descend from it.
- Decided
- Jun 14, 1996
- Review
- 185 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
118 later devices descend from it, 3 citing it directly.
- This deviceK955662 Candela Q-Switched Alexandrite LasersCandela Laser Corp. · 1996
- Descendant · cites it directly · 114 of its ownK063073 Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2006
- Descendant · 2 generations on · 113 of its ownK073534 Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2008
- Descendant · 3 generations on · 112 of its ownK081324 Candela Family of Q-Switched Alexandrite LasersCandela Corp. · 2008
- Descendant · 4 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 5 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 118 · See all- K063073Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2006 · cites it directly114descendants
- K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2008 · 2 generations on113descendants
- K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp. · 2008 · 3 generations on112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 4 generations on111descendants
- K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 5 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955662 | Candela Q-Switched Alexandrite Lasers | Candela Laser Corp. | 1996 | — |
| +1 | K063073 | Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems | Candela Corp. | 2006 | — |
| +2 | K073534 | Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems | Candela Corp. | 2008 | — |
| +3 | K081324 | Candela Family of Q-Switched Alexandrite Lasers | Candela Corp. | 2008 | — |
| +4 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +5 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 6 | 0 |
| 2020 | 11 | 0 |
| 2021 | 8 | 0 |
| 2022 | 18 | 0 |
| 2023 | 9 | 0 |
| 2024 | 13 | 0 |
| 2025 | 14 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | — | Candela Q-Switched Alexandrite Laser (Models PLTL-1 and TL-1) Named without a submission number | |
| * | — | Cynosure Photogenica T10 Tattoo Removal Laser Named without a submission number |
What descends from it? (118)
See all 1183 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, K063073 (Candela Corp., 2006) has gone furthest, with 114 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 | — |
What is it indicated for?
This premarket notification is for the Candela Q-Switched Alexandrite Lasers intended for use in the treatment of pigmented lesions and tattoos.
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/K955662 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955662: Candela Q-Switched Alexandrite Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955662
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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