510(k) · Cleared
ClearedBurane XL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wavelight Laser Technologie AG · GEX Powered Laser Surgical Instrument
Cleared on Feb 24, 2005 as substantially equivalent to K992707 (Aesculap-Meditec North America, 1999) and 5 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1996. 53 later devices descend from it.
- Decided
- Feb 24, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K954013 (1996). 13 ancestors in all. 53 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
- 4 generations backK961748 Medlite/Erbium Laser SystemContinuum Biomedical, Inc. · 1996
- 3 generations backK964128 MCL 29 Dermablate Erbium Laser SystemAesculap-Meditec GmbH · 1997
- 2 generations backK971648 Sharplan Erbium: Yag Laser (4020)Sharplan Lasers, Inc. · 1997
- 1 generation backK981438 Dornier Medilas EDornier Surgical Products, Inc. · 1998
- This deviceK050317 Burane XLWavelight Laser Technologie AG · 2005
- Descendant · cites it directly · 52 of its ownK052806 BuraneWavelight Laser Technologie AG · 2005
- Descendant · 2 generations on · 51 of its ownK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- Descendant · 3 generations on · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- Descendant · 3 generations on · 31 of its ownK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- Descendant · 3 generations on · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K052806BuraneWavelight Laser Technologie AG · 2005 · cites it directly52descendants
- K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 2 generations on51descendants
- K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 3 generations on47descendants
- K092647Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 3 generations on31descendants
- K101626Lensx Laser SystemLensx Lasers, Inc. · 2010 · 3 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954013 | Trilase 2940 Erbium Laser | Schwartz Electro-Optics, Inc. | 1996 | — |
| −4 | K961748 | Medlite/Erbium Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −3 | K964128 | MCL 29 Dermablate Erbium Laser System | Aesculap-Meditec GmbH | 1997 | — |
| −2 | K971648 | Sharplan Erbium: Yag Laser (4020) | Sharplan Lasers, Inc. | 1997 | — |
| −1 | K981438 | Dornier Medilas E | Dornier Surgical Products, Inc. | 1998 | — |
| 0 (this device) | K050317 | Burane XL | Wavelight Laser Technologie AG | 2005 | — |
| +1 | K052806 | Burane | Wavelight Laser Technologie AG | 2005 | — |
| +2 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| +3 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
| +3 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| +3 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K992707 | MCL 29 Dermablate ER:Yag Laser SystemSummary page 1…Plastic Surgery 3. Predicate Devices The BURANE XL laser system is substantially equivalent to the Aesculap- Meditec MCL 29 Dermablate Laser System (K992707 and K964128), the Domier Medilas E Laser (K981438), the Cynosure C03 Er:YAG Laser (K983034), the Laserscope Laser V… | 1999 |
| * | K964128 | MCL 29 Dermablate Erbium Laser SystemSummary page 1…gery 3. Predicate Devices The BURANE XL laser system is substantially equivalent to the Aesculap- Meditec MCL 29 Dermablate Laser System (K992707 and K964128), the Domier Medilas E Laser (K981438), the Cynosure C03 Er:YAG Laser (K983034), the Laserscope Laser VELA (K971843… | 1997 |
| * | K981438 | Dornier Medilas ESummary page 1…RANE XL laser system is substantially equivalent to the Aesculap- Meditec MCL 29 Dermablate Laser System (K992707 and K964128), the Domier Medilas E Laser (K981438), the Cynosure C03 Er:YAG Laser (K983034), the Laserscope Laser VELA (K971843) and the Sciton Er:YAG Laser PROFILE… | 1998 |
| * | K983034 | Cynosure CO3 ER:Yag LaserSummary page 1…to the Aesculap- Meditec MCL 29 Dermablate Laser System (K992707 and K964128), the Domier Medilas E Laser (K981438), the Cynosure C03 Er:YAG Laser (K983034), the Laserscope Laser VELA (K971843) and the Sciton Er:YAG Laser PROFILE 3000 (K040005). 4. Device Description… | 1998 |
| * | K971843 | Laserscope Vela Erbium:Yag Laser System and AccessoriesSummary page 1…29 Dermablate Laser System (K992707 and K964128), the Domier Medilas E Laser (K981438), the Cynosure C03 Er:YAG Laser (K983034), the Laserscope Laser VELA (K971843) and the Sciton Er:YAG Laser PROFILE 3000 (K040005). 4. Device Description BURANE XL is a Er:YAG laser syste… | 1997 |
| * | K040005 | Profile 2000/3000 Laser SystemSummary page 1…Domier Medilas E Laser (K981438), the Cynosure C03 Er:YAG Laser (K983034), the Laserscope Laser VELA (K971843) and the Sciton Er:YAG Laser PROFILE 3000 (K040005). 4. Device Description BURANE XL is a Er:YAG laser system for dermatological interventions and for aestheti… | 2004 |
What descends from it? (53)
See all 531 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052806 | Burane | 2005 | 52 |
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 9 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K052806 (Wavelight Laser Technologie AG, 2005) has gone furthest, with 52 descendants of its own.
- 1 other device also cites its predicate K992707.
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 BURANE XL is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general and all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels…
Read the full statement (289 words)
The BURANE XL is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general and all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The BURANE XL is indicated for use in skin resurfacing. The BURANE XL is indicated for use in medicine and surgery, in the following medical specialities: Dermatology, Plastic Surgery, Gastroenterology, ENT, Thoracic Surgery, Oral & Maxillofacial Surgery, Ophtalmology & Podiatry.
Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.
Dermatology/Plastic Surgery
Indications include, epidermal nevi, telangiectasia, spider veins, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers.
Gastroenterology
General Surgery
The Er:YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during general surgery application where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation.
Genitourinary
Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon.
Gynecology
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
ENT
Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia.
Oral/Maxillofacial
Indications include benign oral tumors, oral and glossal lesions and gingivectomy.
Ophtalmology
Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Podiatry
Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050317: Burane XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050317
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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