510(k) · Cleared
Recalled · 2007Candela Family of Pulse Dye Laser 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 Jun 13, 2005 as substantially equivalent to K043251 (Candela Corp., 2005) and 2 other predicates after a 90-day review. Its family tree reaches back 8 generations to 1991. 133 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 13, 2005
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 8 generations to K904627 (1991). 60 ancestors in all, the oldest K882160 (1988). 133 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
- 7 generations backK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
- 6 generations backK972347 Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc. · 1997
- 5 generations backK993671 Candela Sclero Long Pulse Dye LaserCandela Corp. · 2000
- 4 generations backK013748 Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002
- 3 generations backK021180 Candela Vbeam Pulsed Dye Laser SystemCandela Corp. · 2002
- 2 generations backK033461 Candela Vbeam Pulse Dye Laser SystemCandela Corp. · 2004
- 1 generation backK043251 Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam…Candela Corp. · 2005
- This deviceK050673 Candela Family of Pulse Dye Laser SystemsCandela Corp. · 2005
- Descendant · cites it directly · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- Descendant · 2 generations on · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 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
Showing 5 of 133 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 133 · See all- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · cites it directly129descendants
- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 2 generations on112descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904627 | Centauri Yag Laser Syst, Ear, Nose , Throat | Pfizer Laser Systems | 1991 | — |
| −7 | K960032 | Coherent Versapulse Aesthetic Surgical Lasers | Coherent Medical Group | 1996 | — |
| −6 | K972347 | Modified Coherent Versapulse Aesthetic Surgical Laser | Lumenis, Inc. | 1997 | — |
| −5 | K993671 | Candela Sclero Long Pulse Dye Laser | Candela Corp. | 2000 | — |
| −4 | K013748 | Candela Sclero Long Pulse Laser (Aka Vbeam) | Candela Corp. | 2002 | — |
| −3 | K021180 | Candela Vbeam Pulsed Dye Laser System | Candela Corp. | 2002 | — |
| −2 | K033461 | Candela Vbeam Pulse Dye Laser System | Candela Corp. | 2004 | — |
| −1 | K043251 | Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B | Candela Corp. | 2005 | — |
| 0 (this device) | K050673 | Candela Family of Pulse Dye Laser Systems | Candela Corp. | 2005 | — |
| +1 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| +2 | K081352 | Profile Multi-Platform System | Sciton, Inc | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 10 | 0 |
| 2019 | 8 | 0 |
| 2020 | 11 | 0 |
| 2021 | 9 | 0 |
| 2022 | 18 | 0 |
| 2023 | 10 | 0 |
| 2024 | 14 | 0 |
| 2025 | 15 | 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 |
|---|---|---|---|
| * | K043251 | Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BSummary page 1…r, Candela Family of Pulse Dye Laser Systems Predicate Devices: Candela Family of Pulsed Dye Lasers - K043251I Cynosure VStar (Tristar PDL) - K033 176, K032565 Dtesciptin The Candela Family of Pulsed Dye… | 2005 |
| * | K033176 | Tristar Aesthetic Workstation LaserSummary page 1…Predicate Devices: Candela Family of Pulsed Dye Lasers - K043251I Cynosure VStar (Tristar PDL) - K033 176, K032565 Dtesciptin The Candela Family of Pulsed Dye Laser Systems are 585, 595nm flash-lamp excited pulse dye medical lasers,… | 2004 |
| * | K032565 | Cynosure Photogenica VLSummary page 1…icate Devices: Candela Family of Pulsed Dye Lasers - K043251I Cynosure VStar (Tristar PDL) - K033 176, K032565 Dtesciptin The Candela Family of Pulsed Dye Laser Systems are 585, 595nm flash-lamp excited pulse dye medical lasers, indicated… | 2003 |
What descends from it? (133)
See all 1333 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 |
|---|---|---|---|---|
| Jan 15, 2007 | Not classified | Z-0508-2007 | Other | Internal component may overheat causing the possibility of risk of fire or smoke |
| 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 14 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 60 ancestors has a recall of any class.
- Of its descendants, K070388 (Sciton, Inc, 2007) has gone furthest, with 129 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 is indicated for the following uses General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions. Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and…
Read the full statement (100 words)
The Candela Family of Pulse Dye Laser Systems is indicated for the following uses
General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis and the treatment of wrinkles. Treatment of Benign Epidermal Pigmented Lesions. Treatment of Inflammatory Acne Vulgaris
Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
Podiatry: Treatment of benign cutaneous lesions, such as warts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050673: Candela Family of Pulse Dye Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050673
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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