510(k) · Cleared
ClearedBurane
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 Oct 17, 2005 as substantially equivalent to K992707 (Aesculap-Meditec North America, 1999) and 6 other predicates after a 13-day review. Its family tree reaches back 6 generations to 1996. 52 later devices descend from it.
- Decided
- Oct 17, 2005
- Review
- 13 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K954013 (1996). 14 ancestors in all. 52 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
- 5 generations backK961748 Medlite/Erbium Laser SystemContinuum Biomedical, Inc. · 1996
- 4 generations backK964128 MCL 29 Dermablate Erbium Laser SystemAesculap-Meditec GmbH · 1997
- 3 generations backK971648 Sharplan Erbium: Yag Laser (4020)Sharplan Lasers, Inc. · 1997
- 2 generations backK981438 Dornier Medilas EDornier Surgical Products, Inc. · 1998
- 1 generation backK050317 Burane XLWavelight Laser Technologie AG · 2005
- This deviceK052806 BuraneWavelight Laser Technologie AG · 2005
- Descendant · cites it directly · 51 of its ownK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- Descendant · 2 generations on · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- Descendant · 2 generations on · 31 of its ownK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- Descendant · 2 generations on · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- Descendant · 3 generations on · 19 of its ownK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · cites it directly51descendants
- K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 2 generations on47descendants
- K092647Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 2 generations on31descendants
- K101626Lensx Laser SystemLensx Lasers, Inc. · 2010 · 2 generations on30descendants
- K113151Ifs Laser SystemAbbott Medical Optics, Inc. · 2012 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954013 | Trilase 2940 Erbium Laser | Schwartz Electro-Optics, Inc. | 1996 | — |
| −5 | K961748 | Medlite/Erbium Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −4 | K964128 | MCL 29 Dermablate Erbium Laser System | Aesculap-Meditec GmbH | 1997 | — |
| −3 | K971648 | Sharplan Erbium: Yag Laser (4020) | Sharplan Lasers, Inc. | 1997 | — |
| −2 | K981438 | Dornier Medilas E | Dornier Surgical Products, Inc. | 1998 | — |
| −1 | K050317 | Burane XL | Wavelight Laser Technologie AG | 2005 | — |
| 0 (this device) | K052806 | Burane | Wavelight Laser Technologie AG | 2005 | — |
| +1 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| +2 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
| +2 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| +2 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
| +3 | K113151 | Ifs Laser System | Abbott Medical Optics, Inc. | 2012 | — |
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 |
|---|---|---|
| 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? (7)
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…y and Plastic Surgery 3. Predicate Devices The BURANE laser system is substantially equivalent to the Aesculap- Meditec MCL 29 Dermnablate Laser System (K992707 and K(964128), the Domier Medilas E Laser (K(951438), the Cynosure C03 Er:YAG Laser (K983034), the Laserscope Laser V… | 1999 |
| * | K964128 | MCL 29 Dermablate Erbium Laser SystemSummary page 1…Surgery 3. Predicate Devices The BURANE laser system is substantially equivalent to the Aesculap- Meditec MCL 29 Dermnablate Laser System (K992707 and K(964128), the Domier Medilas E Laser (K(951438), the Cynosure C03 Er:YAG Laser (K983034), the Laserscope Laser VELA (K971 843… | 1997 |
| * | K981438 | Dornier Medilas E Our reading of the summary gave K951438, FDA’s number for Benson and Ashley (Benson & Ashley, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Dornier Medilas E Laser”. | 1998 |
| * | K983034 | Cynosure CO3 ER:Yag LaserSummary page 1…to the Aesculap- Meditec MCL 29 Dermnablate Laser System (K992707 and K(964128), the Domier Medilas E Laser (K(951438), the Cynosure C03 Er:YAG Laser (K983034), the Laserscope Laser VELA (K971 843), the WaveLight BURANE XL (1(050317) and the Sciton Er:YAG Laser PROFILE 3000 (K04000… | 1998 |
| * | K971843 | Laserscope Vela Erbium:Yag Laser System and AccessoriesSummary page 1…9 Dermnablate Laser System (K992707 and K(964128), the Domier Medilas E Laser (K(951438), the Cynosure C03 Er:YAG Laser (K983034), the Laserscope Laser VELA (K971 843), the WaveLight BURANE XL (1(050317) and the Sciton Er:YAG Laser PROFILE 3000 (K040005). 4. Device Description… | 1997 |
| * | K050317 | Burane XLSummary page 1…4128), the Domier Medilas E Laser (K(951438), the Cynosure C03 Er:YAG Laser (K983034), the Laserscope Laser VELA (K971 843), the WaveLight BURANE XL (1(050317) and the Sciton Er:YAG Laser PROFILE 3000 (K040005). 4. Device Description BURANE is a Er:YAG laser system for dermn… | 2005 |
| * | K040005 | Profile 2000/3000 Laser SystemSummary page 1…, the Cynosure C03 Er:YAG Laser (K983034), the Laserscope Laser VELA (K971 843), the WaveLight BURANE XL (1(050317) and the Sciton Er:YAG Laser PROFILE 3000 (K040005). 4. Device Description BURANE is a Er:YAG laser system for dermnatological interventions and for aesthetic l… | 2004 |
What descends from it? (52)
See all 521 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082947 | Lensx 550 Laser System | 2009 | 51 |
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 14 ancestors has a recall.
- Of its descendants, K082947 (Lensx Lasers, Inc., 2009) has gone furthest, with 51 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 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 (283 words)
The BURANE 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 is indicated for use in skin resurfacing. The BURANE is indicated for use in medicine and surgery, in the following medical specialities: Dermatology, Plastic Gastroenterology, ENT, Thoracic Surgery, Oral & Maxillofacial Surgery, Ophtalmology & Podiatry.
Aesthetic Sumery
Skin resurfacing and treatment of wrinkles.
Dermatology/Plastic Surgery
Indications include, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers.
Gastroenterolopy
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.
Genitoudna
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, endometria hesions, cy
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.
Ophtalmoloqy
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/K052806 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052806: Burane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052806
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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