510(k) · Cleared
ClearedAura Dye Laser System (Adls)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laserscope · GEX Powered Laser Surgical Instrument
Cleared on Mar 5, 1999 after an 84-day review. The FDA summary names its predicate without a number. 137 later devices descend from it.
- Decided
- Mar 5, 1999
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
137 later devices descend from it, 1 citing it directly.
- This deviceK984424 Aura Dye Laser System (Adls)Laserscope · 1999
- Descendant · cites it directly · 136 of its ownK043251 Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam…Candela Corp. · 2005
- Descendant · 2 generations on · 133 of its ownK050673 Candela Family of Pulse Dye Laser SystemsCandela Corp. · 2005 · Recalled
- Descendant · 2 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- Descendant · 3 generations on · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
- Descendant · 3 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Showing 5 of 137 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 137 · See all- K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp. · 2005 · cites it directly136descendants
- K050673Candela Family of Pulse Dye Laser SystemsCandela Corp. · 2005 · 2 generations on133descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 2 generations on129descendants
- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 3 generations on112descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 3 generations on111descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984424 | Aura Dye Laser System (Adls) | Laserscope | 1999 | — |
| +1 | K043251 | Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B | Candela Corp. | 2005 | — |
| +2 | K050673 | Candela Family of Pulse Dye Laser Systems | Candela Corp. | 2005 | 2 |
| +2 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| +3 | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
| +3 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | — | Laserscope Aura laser system Named without a submission number | |
| * | — | Laserscope Orion laser system Named without a submission number | |
| * | — | Coherent Versa Pulse C laser system Named without a submission number | |
| * | — | Candela ScleroPulse laser system Named without a submission number | |
| * | — | Cynosure PhotoGenica LV laser system Named without a submission number |
What descends from it? (137)
See all 1371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043251 | Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B | 2005 | 136 |
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?
- Of its descendants, K043251 (Candela Corp., 2005) has gone furthest, with 136 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 Laserscope Aura Dye Laser System and Accessories are intended for the surgical Incislonvexcision, vaparization, ablation and coagulation of sott tissue. “All soft tissue is Included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, musdle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Dermatology/Plastic Surgery:indications include epidermal nevi, telangiectasia, spidé} veins…
Read the full statement (213 words)
The Laserscope Aura Dye Laser System and Accessories are intended for the surgical Incislonvexcision, vaparization, ablation and coagulation of sott tissue. “All soft tissue is Included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, musdle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Dermatology/Plastic Surgery:indications include epidermal nevi, telangiectasia, spidé} veins, verrucae, skin tags, anal tags, keratoses, debulking benign tumors and cysts, superficial skin lesions, and benign pigmented lesions.
General Surgery: Indications include surgical incision/excision, vaporization, ablation and coagulation of soft tissue where skin incision, tissue dissection, excision of extemal tumors and lesions, complete or partial resection of intemmal organs, tumors and lesions, tissue ablations andfor vessel coagulation may. be indicated.
Genitourinary: Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyloma acuminata, giant perineal condyloma and verruccous carcinoma), vulvar tasions, polyps and familia! polyps of the colon.
Gynecology: Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma.
OralMaxillofacial:Indications include benign oral tumocs, oral and glossal lesions.
Otorhinolaryngology/Head and Neck (ENT): Indications include ear, nose and throat lesions, polyps, cysts, excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology: Indications include soft tissue surrounding the eye and orbit..
Podiatry: Indications include wart, plantar verrucae, and farge mosiac verrucae.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984424: Aura Dye Laser System (Adls).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984424
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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