510(k) · Cleared
Recalled · 2006Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece Accessory
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 Jul 13, 2005 as substantially equivalent to K043251 (Candela Corp., 2005) and 1 other predicate after a 50-day review. Its family tree reaches back 9 generations to 1992. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 13, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 9 generations to K910422 (1992). 166 ancestors in all, the oldest K820106 (1982). 1 later device descends 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 backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- This deviceK051359 Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion…Candela Corp. · 2005
- Descendant · cites it directly · 0 of its ownK060977 Medlite C Series Compression Tool and Handpiece Attachment…Hoya Conbio, Inc. · 2006
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 backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- This deviceK051359 Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion…Candela Corp. · 2005
Most influential descendants
Showing 1 of 1 · See all- K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc. · 2006 · cites it directly0descendants
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 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| 0 (this device) | K051359 | Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece Accessory | Candela Corp. | 2005 | — |
| +1 | K060977 | Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model… | Hoya Conbio, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 8 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 9 | 0 |
| 1997 | 12 | 0 |
| 1998 | 9 | 0 |
| 1999 | 8 | 0 |
| 2000 | 17 | 0 |
| 2001 | 19 | 0 |
| 2002 | 24 | 0 |
| 2003 | 18 | 0 |
| 2004 | 8 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043251 | Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BSummary page 1…ndela Famiuly of Pulse Dye Laser Systems Predicate Devices: Candela Family of Pulsed Dye Lasers - K043251 MSQ Family of Laser/Light System Handpieces - K040200 Lumen… | 2005 |
| * | K042000 | Modified MSQ Family of Lovely Light/Laser Systems Our reading of the summary gave K040200, FDA’s number for Mesacup-2 Test Cenp-B (Rhigene, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “MSQ Family of Laser/Light System Handpieces”. | 2004 |
| Kept off the family tree | K011746 | FDA’s K011746 is MB 11 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060977 | Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523 | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 17, 2006 | Not classified | Z-0842-06 | Other | Handle fires even when the finger is off the switch |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 166 ancestors have a recall of any class.
- Of its descendants, K060977 (Hoya Conbio, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K043251.
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 Family of Pulse Dye Laser Systems Pigmented Lesion Handpiece Accessory is indicated for the Treatment of Benign Epidermal Pigmented Lesions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051359: Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051359
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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