510(k) · Cleared
ClearedCandela Vbeam Pulse Dye 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 Jan 16, 2004 as substantially equivalent to K021180 (Candela Corp., 2002) and 1 other predicate after a 78-day review. Its family tree reaches back 6 generations to 1991. 316 later devices descend from it.
- Decided
- Jan 16, 2004
- Review
- 78 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K904627 (1991). 36 ancestors in all, the oldest K882160 (1988). 316 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
- 5 generations backK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
- 4 generations backK972347 Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc. · 1997
- 3 generations backK993671 Candela Sclero Long Pulse Dye LaserCandela Corp. · 2000
- 2 generations backK013748 Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002
- 1 generation backK021180 Candela Vbeam Pulsed Dye Laser SystemCandela Corp. · 2002
- This deviceK033461 Candela Vbeam Pulse Dye Laser SystemCandela Corp. · 2004
- Descendant · cites it directly · 205 of its ownK053047 Fraxel SR Laser SystemReliant Technologies, Inc. · 2006
- Descendant · cites it directly · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · 2 generations on · 195 of its ownK063038 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- Descendant · 2 generations on · 194 of its ownK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- Descendant · 3 generations on · 187 of its ownK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
Showing 5 of 316 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 316 · See all- K053047Fraxel SR Laser SystemReliant Technologies, Inc. · 2006 · cites it directly205descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · cites it directly198descendants
- K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007 · 2 generations on195descendants
- K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007 · 2 generations on194descendants
- K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008 · 3 generations on187descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904627 | Centauri Yag Laser Syst, Ear, Nose , Throat | Pfizer Laser Systems | 1991 | — |
| −5 | K960032 | Coherent Versapulse Aesthetic Surgical Lasers | Coherent Medical Group | 1996 | — |
| −4 | K972347 | Modified Coherent Versapulse Aesthetic Surgical Laser | Lumenis, Inc. | 1997 | — |
| −3 | K993671 | Candela Sclero Long Pulse Dye Laser | Candela Corp. | 2000 | — |
| −2 | K013748 | Candela Sclero Long Pulse Laser (Aka Vbeam) | Candela Corp. | 2002 | — |
| −1 | K021180 | Candela Vbeam Pulsed Dye Laser System | Candela Corp. | 2002 | — |
| 0 (this device) | K033461 | Candela Vbeam Pulse Dye Laser System | Candela Corp. | 2004 | — |
| +1 | K053047 | Fraxel SR Laser System | Reliant Technologies, Inc. | 2006 | — |
| +1 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +2 | K063038 | Fraxel Iii SR Laser System and Accessories | Reliant Technologies, Inc. | 2007 | — |
| +2 | K071051 | Fraxel Iii SR Laser System and Accessories | Reliant Technologies, Inc. | 2007 | — |
| +3 | K080915 | Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories | Reliant Technologies, Inc. | 2008 | — |
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 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 11 | 0 |
| 2009 | 6 | 0 |
| 2010 | 7 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 12 | 0 |
| 2015 | 15 | 0 |
| 2016 | 16 | 0 |
| 2017 | 17 | 0 |
| 2018 | 21 | 0 |
| 2019 | 12 | 0 |
| 2020 | 20 | 0 |
| 2021 | 17 | 0 |
| 2022 | 30 | 0 |
| 2023 | 19 | 0 |
| 2024 | 34 | 0 |
| 2025 | 35 | 0 |
| 2026 | 20 | 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 |
|---|---|---|---|
| * | K021180 | Candela Vbeam Pulsed Dye Laser SystemSummary page 1…necology, treatment of wrinkles and the treatment of inflammatory acne vulgaris. There have been no modifications to design to the Vbeam Pulse Dye Laser as cleared under K 021180. Submitted by: Candela Corporation 530 Boston Post Road… | 2002 |
| * | K024189 | Nlite System, Model#: A00-1025/A00-1033Summary page 1…ogy Laser, Vbeam Pulse Dye Laser System Predicate Devices: Candela Vbeam Pulse Dye Laser (K021180),, ICN Photonics NLite (K024189) Description: The Vbeam is a 595 nm flash-lamp excited pulse dye medical laser, controlled by an embedded microprocessor., to b… | 2003 |
What descends from it? (316)
See all 3165 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053047 | Fraxel SR Laser System | 2006 | 205 |
| K083899 | Revlite Q-Switched ND:Yag Laser System | 2009 | 198 |
| K043251 | Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B | 2005 | 136 |
| K070388 | Profile Multi-Platform System | 2007 | 129 |
| K150907 | Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner… | 2015 | 5 |
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 13 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 36 ancestors has a recall.
- Of its descendants, K053047 (Reliant Technologies, Inc., 2006) has gone furthest, with 205 descendants of its own.
- 3 other devices also cite its predicate K021180.
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 Vbeam Pulse Dye Laser is indicated for the following uses in: General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions. Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, 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.…
Read the full statement (95 words)
The Candela Vbeam Pulse Dye Laser is indicated for the following uses in:
General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions.
Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, 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.
New indication: Treatment of Inflammatory Acne Vulgaris
Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology.
Podiatry: Treatment of benign cutaneous lesion, such as warts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033461 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033461: Candela Vbeam Pulse Dye Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033461
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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