BURANE XL

K050317 · Wavelight Laser Technologie AG · GEX · Feb 24, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050317
• Device Name: BURANE XL
• Applicant: Wavelight Laser Technologie AG
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The BURANE XL is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in an open surgical procedure are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, striated 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.

Device Story

The BURANE XL is an Er:YAG laser system (2.94 µm wavelength) designed for dermatological and aesthetic interventions. It utilizes triple-mode technology, allowing the physician to select between Ablation Mode, Coagulation Mode, or a combination of both. The device operates by delivering laser energy to target soft tissue; the 2.94 µm wavelength is highly absorbed by water, enabling precise ablation with minimal thermal damage to surrounding tissue, thereby promoting optimal wound healing and reducing scar formation. The treating physician selects parameters including spot size, laser energy, pulse sequence, and coagulation function to adjust for individual patient requirements. It is intended for use by trained medical professionals in clinical settings across multiple surgical specialties.

Clinical Evidence

No clinical data presented; bench testing only.

Technological Characteristics

Er:YAG laser system; wavelength 2.94 µm. Features triple-mode technology (Ablation, Coagulation, and combination). Adjustable parameters include spot size, laser energy, and pulse sequence. Designed for dermatological and surgical soft tissue applications.

Indications for Use

Indicated for surgical incision, excision, vaporization, ablation, and coagulation of soft tissue and cartilage across various specialties including dermatology, plastic surgery, gastroenterology, ENT, thoracic surgery, oral/maxillofacial surgery, ophthalmology, and podiatry. Specific applications include skin resurfacing, wrinkle treatment, epidermal nevi, telangiectasia, spider veins, actinic keratoses, scar revision, debulking benign tumors, decubitus ulcers, genitourinary lesions (condyloma, polyps), gynecological conditions (CIN, adhesions, cysts), ENT lesions, oral/glossal lesions, gingivectomy, and podiatric procedures (warts, matrixectomy).

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Aesculap-Medited MCL 29 Dermablate Laser System (K992707 and K964128)
• Dornier Medilas E Laser (K981438)
• Cynosure CO3 Er:YAG Laser (K983034)
• Laserscope Laser VELA (K971843)
• Sciton Er:YAG Laser PROFILE 3000 (K040005)

Submission Summary (Full Text)

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Wavelight Burane XL: 510(k) Review January 20, 2005

K 050317

510K Summary

FEB 2 4 2005

WaveLight®

510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance rills 810(t) Samments of the SMDA 1990 and 21 CFR 807.92.

### 1. General Information

WaveLight Laser Technologie, AG Submitter: Am Wolfsmantel 5 91058 Erlangen Germany Alexander Popp Contact Person: Am Wolfsmantel 5 91058 Erlangen Germany Telephone: [phone] Fax: [phone] July 30, 2004 Summary Preparation Date:

- 2. Names
Device Name:

BURANE XL

Classification Name:

Laser Instrument, Surgical Powered Product Code: GEX Panel: Dermatology and Plastic Surgery

## 3. Predicate Devices

The BURANE XL laser system is substantially equivalent to the Aesculap-Medited MCL 29 Dermablate Laser System (K992707 and K964128), the Dornier Medilas E Laser (K981438), the Cynosure CO3 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 aesthetic laser applications. The triple mode technology makes BURANE for aestheric ideor upphodibensial controllable Coagualtion Mode for different AL an export dother the Ablation Mode for classical ablation procedures, and the combination of both techniques.

0029

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K050J17

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Wavelight Burane XL: 510(k) Review January 20, 2005

510K Summary (con't)

S WaveLight®

510(k) Summary of Safety and Effectiveness

Furthermore, the laser system enables a quick, precise ablation with minimal Furthermore, the laser System enables a quion process is achieved.
thermal tissue damage. Thus an optimal wound health PULPANE YL's thermal tissue damage. Thus an optimal wear in the BURANE XL's
-- the risk of scar formation is minimized. This is due to the BURANE XL's -- the risk of scar lomation is minimized. This is and is water and is wavelength of 2.94 pm, which has an absorplane in thermal damage zone is thus minimized.

While the parameters wavelength and pulse form are specified by the device, While the parameters wavelengin and patool coagulation function can be
spot size, laser energy, pulse sequence, and coaggitation function can be spot size, laser encry), pullos soquenest ...
selected by the treating physician for optimal adjustment to individual requirements.

## 5. Indications for Use

The BURANE XL is indicated:

The BURANE XL is intended to be used in small and large joint arthroscopy, The BURANE XL is intendou to be ad all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and including the may be many ablem, and surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, in this indication such as, Skiff, Gutanoous neartilage, meniscus, mucous membrane, stratted and smooth tissue, music, organs and glands. The BURANE XL is indicated lymph vessels and nodes, organs and grands. Indicated for use in medicine
for use in skin resurfacing. The BURANE XL is indicated for use in medicine for use in skirl resultacing. The Born specialities: Dermatology, Plastic and surgery, in the following medical Spotlallabor Spotland of July 2017 - 11:40
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, actinio Indications Include, epidennal nevi, colangiocacial, spiratoses, scar revision, debulking benign tumors, decubitis ulcers.

#### Gastroenterology

#### General Surgery

The Er:YAG laser is intended for the surgical incision/excision, vaporization The E.TAG laser is intended for the ourgery application where skin and coaguiation of Solt lissue duning general tumors and lesions, complete Incision, itssue dissection, oxolori of oxecions, tissue ablation and/or vessel coagulation.

0030

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K050317
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Wavelight Burane XL: 510(k) Review January 20, 2005

510K Summary (con't)

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# 510(k) Summary of Safety and Effectiveness

#### Genitourinary

Genitourinary
Indications include lesions of the external genitalia, urethra and anus, penis, Indications Include lesions of the external geniture, giant perineal scrotum and urethra (includes condyloma deaminene) ,
condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon.

#### Gynecology

്യന്മാവിമയ്ക്കും.
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, molometrial adhesions, cysts and condyloma.

#### ENT

Indications include ear, nose and throat lesions, polyps, cysts, indications include car, nooo and the tic tissue, oral leukoplakia.

Oral/Maxillofacial Oral/Maxilloracial
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

Podiatry
Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.

- 6. Performance Data None presented.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing the agency's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Public Health Service

FEB 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wavelight Laser Technologie AG c/o Mr. William J. Sammons Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, North Carolina 27709

Re: K050317 Trade/Device Name: Burane XL Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 20, 2005 Received: February 9, 2005

Dear Mr. Sammons:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. William J. Sammons

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Stipt Rhodes

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Wavelight Burane XL: 510(k) Review January 20, 2005 Indication for use

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#### 510 (k) Indications for Use

Indications for Use 510(k) Number (if known): N# K 05D 317 BURANE XL Device Name:

#### Indications for Use:

The BURANE XL is intended to be used in small and large joint arthroscopy, The BURANE XE is intendou to be ad all surgical procedures for laparoscopic procedures, gonoral ation, and coagulation of soft tissue and incision/excision, vaporization, abliation, and surgical procedures are included in cartilage. All soll lissues encountered in an subcutaneous tissue, straited and this indication such as, skin, outainous, meniscus, membrane, lymph vessels
smooth tissue, muscle, cartilage, meniscus, meniscus, men in clin smooth tissue, muscle, cartilage, membodo, macered for use in skin and nodes, organis and grands. The Beard for use in medicine and surgery, in the resultacing. The DONANE AE is included in Plastic Gastroenterology, ENT, following medical specialities: Domiatology, Ophtalmology & Podiatry.

Aesthetic Surgery

Skin resurfacing and treatment of wrinkles.

### Dermatology/Plastic Surgery

Dermatology/Flastic ാവ്യല്‍
Indications include, epidermal nevi, telangiectasia, spider veins, adabulking Indications include, epidential nove, totanges, scar revision, debulking benign tumors, decubitis ulcers.

Gastroenterology

#### General Surgery

General Surgery
The Er:YAG laser is intended for the surgical incision/excision, vaporization and The E.Y.AG laser is intended for the ourgery application where skin indision, coagulation of solt trisde duning general cargony desions, complete or partial tissue dissection, excision of extornal tamble and lesions, tissue ablation and/or vessel coaqulation.

#### Genitourinary

Indications include lesions of the external genitalia, urethra and anus, penis, Indications Include lesions of the oxtomal genminate, giant perineal condyloma
scrotum and urethra (includes condyloma acuminate, giant perineal condyloma scrolum and their a (inoludos contactions, polyps and familial polyps of the colon.

#### Gynecology

Gynecology
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, muloations include ons, cysts and condyloma.

0027

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## 510 (k) Indications for Use

## 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 qinqivectomy.

### Ophtalmology

Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.

### Podiatry

Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
|-------------------------------------------------|---|

AND/OR

| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | N/A |
|------------------------------------------------|-----|
|------------------------------------------------|-----|

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED)## Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Page 1 ol (indication for use only

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number**: K050317