510(k) · Cleared
ClearedCandela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems
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 Apr 3, 2008 as substantially equivalent to K063073 (Candela Corp., 2006) and 2 other predicates after a 108-day review. Its family tree reaches back 9 generations to 1992. 113 later devices descend from it.
- Decided
- Apr 3, 2008
- Review
- 108 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K910422 (1992). 65 ancestors in all, the oldest K892514 (1990). 113 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 2 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 1 generation backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- This deviceK073534 Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2008
- Descendant · cites it directly · 112 of its ownK081324 Candela Family of Q-Switched Alexandrite LasersCandela Corp. · 2008
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- Descendant · 4 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- Descendant · 3 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
Show all 9 generations
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 7 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 6 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 5 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 4 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 3 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 2 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 1 generation backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- This deviceK073534 Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp. · 2008
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 113 · See all- K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp. · 2008 · cites it directly112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
- K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants
- K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 4 generations on62descendants
- K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · 3 generations on57descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −8 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −6 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −5 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −4 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −3 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −2 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −1 | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| 0 (this device) | K073534 | Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems | Candela Corp. | 2008 | — |
| +1 | K081324 | Candela Family of Q-Switched Alexandrite Lasers | Candela Corp. | 2008 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +3 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| +4 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| +3 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K063073 | Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsSummary page 1…21 CFR § 878.4810 Device Classification: II Identification of Predicate Device Predicate Device(s): Candela Q-Switched Alexandrite Laser, (AlexLkzR), K063073 Candela 3630 Laser Systems, Alexandrite, K063074 Cynosure Apogee… | 2006 |
| * | K063074 | Candela 3630 Laser SystemSummary page 1…evice Predicate Device(s): Candela Q-Switched Alexandrite Laser, (AlexLkzR), K063073 Candela 3630 Laser Systems, Alexandrite, K063074 Cynosure Apogee Elite Laser, Alexandrite, K034030 Device Description The Candela Family of Q-Sw… | 2006 |
| * | K034030 | Apogee EliteSummary page 1…LkzR), K063073 Candela 3630 Laser Systems, Alexandrite, K063074 Cynosure Apogee Elite Laser, Alexandrite, K034030 Device Description The Candela Family of Q-Switched Alexandrite Laser (AleXLAZR) systems consist of an Alexandrite laser head,… | 2004 |
What descends from it? (113)
See all 1131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081324 | Candela Family of Q-Switched Alexandrite Lasers | 2008 | 112 |
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?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 65 ancestors have a recall of any class.
- Of its descendants, K081324 (Candela Corp., 2008) has gone furthest, with 112 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. 2008, this device’s year, is highlighted.
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 Family of Q-Switched Alexandrite Laser (Alexi~zR) systems is indicated for the following uses:
Pigmented Lesions
Tattoos
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073534 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073534: Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073534
Report an extraction error
Are you the manufacturer?
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