# K052806: Burane

- Pathway: 510(k) (Traditional)
- Applicant: Wavelight Laser Technologie AG
- Decided: Oct 17, 2005 after 13 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K954013 (1996). 14 ancestors in all.
52 later devices descend from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992707: MCL 29 Dermablate ER:Yag Laser System, Aesculap-Meditec North America (1999) Summary page 1.
- K964128: MCL 29 Dermablate Erbium Laser System, Aesculap-Meditec GmbH (1997) Summary page 1.
- K981438: Dornier Medilas E, Dornier Surgical Products, Inc. (1998). 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”.
- K983034: Cynosure CO3 ER:Yag Laser, Cynosure, Inc. (1998) Summary page 1.
- K971843: Laserscope Vela Erbium:Yag Laser System and Accessories, Laserscope (1997) Summary page 1.
- K050317: Burane XL, Wavelight Laser Technologie AG (2005) Summary page 1.
- K040005: Profile 2000/3000 Laser System, Sciton, Inc (2004) Summary page 1.

## Most influential descendants
- K082947: Lensx 550 Laser System (2009), 51 descendants of its own
- K094052: Lensx 550 Laser System. Model 550 (2010), 47 descendants of its own
- K092647: Lensx 550 Laser System (2009), 31 descendants of its own
- K101626: Lensx Laser System (2010), 30 descendants of its own
- K113151: Ifs Laser System (2012), 19 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K052806
Methodology: https://510kreport.com/methodology