510(k) · Cleared
ClearedCandela Cbeam 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 K020958 (Candela Corp., 2002) and 1 other predicate after a 92-day review. Its family tree reaches back 3 generations to 2000. 230 later devices descend from it.
- Decided
- Jan 16, 2004
- Review
- 92 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000811 (2000). 6 ancestors in all. 230 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK000811 Nlite System, SLS Model Number A00-1025Sls Biophile, Ltd. · 2000
- 2 generations backK013043 Candela Clearbeam Pulsed Dye LaserCandela Corp. · 2001
- 1 generation backK020958 Candela Cbeam Pulsed Dye Laser SystemCandela Corp. · 2002
- This deviceK033331 Candela Cbeam Pulse Dye Laser SystemCandela Corp. · 2004
- Descendant · cites it directly · 205 of its ownK053047 Fraxel SR Laser SystemReliant Technologies, Inc. · 2006
- 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
- Descendant · 4 generations on · 158 of its ownK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
Showing 5 of 230 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 230 · See all- K053047Fraxel SR Laser SystemReliant Technologies, Inc. · 2006 · cites it directly205descendants
- 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
- K083900Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009 · 4 generations on158descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000811 | Nlite System, SLS Model Number A00-1025 | Sls Biophile, Ltd. | 2000 | — |
| −2 | K013043 | Candela Clearbeam Pulsed Dye Laser | Candela Corp. | 2001 | — |
| −1 | K020958 | Candela Cbeam Pulsed Dye Laser System | Candela Corp. | 2002 | — |
| 0 (this device) | K033331 | Candela Cbeam Pulse Dye Laser System | Candela Corp. | 2004 | — |
| +1 | K053047 | Fraxel SR Laser System | Reliant Technologies, Inc. | 2006 | — |
| +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 | — |
| +4 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 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 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 10 | 0 |
| 2016 | 9 | 0 |
| 2017 | 9 | 0 |
| 2018 | 16 | 0 |
| 2019 | 9 | 0 |
| 2020 | 16 | 0 |
| 2021 | 11 | 0 |
| 2022 | 23 | 0 |
| 2023 | 16 | 0 |
| 2024 | 25 | 0 |
| 2025 | 26 | 0 |
| 2026 | 12 | 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 |
|---|---|---|---|
| * | K020958 | Candela Cbeam 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 Cbeam Pulse Dye Laser as cleared under K020958. Submitted by: Candela Corporation 530 Boston Post Road… | 2002 |
| * | K024189 | Nlite System, Model#: A00-1025/A00-1033Summary page 1…ogy Laser, Cbearn Pulse Dye Laser System Predicate Devices: Candela Cbeam Pulse Dye Laser (K020958), lCN Photonics NLite (K024 189) Description: The Cbearn is a 585 nm flash-lamp excited pulse dye medical laser, controlled by an embedded microprocessor., to… | 2003 |
What descends from it? (230)
See all 2303 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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K053047 (Reliant Technologies, Inc., 2006) has gone furthest, with 205 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?
The Candela Cbeam 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.
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/K033331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033331: Candela Cbeam Pulse Dye Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033331
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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