BURANE

K052806 · Wavelight Laser Technologie AG · GEX · Oct 17, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052806
• Device Name: BURANE
• Applicant: Wavelight Laser Technologie AG
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended 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.

Device Story

BURANE is an Er:YAG laser system (2.94 µm wavelength) for dermatological and surgical soft tissue interventions. Device utilizes high water absorption of 2.94 µm wavelength to achieve precise tissue ablation with minimal thermal damage. Physician selects parameters including spot size, laser energy, pulse sequence, and coagulation mode to tailor treatment to individual patient requirements. Used by surgeons and clinicians in clinical settings for procedures ranging from skin resurfacing to internal organ resection. Output is laser energy delivered to target tissue; enables controlled incision, excision, vaporization, and coagulation. Benefits include optimized wound healing and reduced thermal damage to surrounding tissue.

Clinical Evidence

No clinical data presented. Bench testing only.

Technological Characteristics

Er:YAG laser system; 2.94 µm wavelength; Ablation and Coagulation modes. Adjustable parameters: spot size, laser energy, pulse sequence. Class II medical device.

Indications for Use

Indicated for incision, excision, vaporization, ablation, and coagulation of soft tissue and cartilage across various specialties including dermatology, plastic surgery, gastroenterology, ENT, thoracic, oral/maxillofacial, ophthalmology, and podiatry. Specific applications include skin resurfacing, wrinkle treatment, lesion removal (nevi, keloids, verrucae, tags, keratoses, tumors, ulcers), scar revision, vessel coagulation, and various procedures in gynecology (CIN, adhesions, cysts), genitourinary, and podiatry (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-Meditec MCL 29 Dermablate Laser System (K992707 and K964128)
• Domier Medilas E Laser (K981438)
• Cynosure CO3 Er:YAG Laser (K983034)
• Laserscope Laser VELA (K971843)
• WaveLight BURANE XL (K050317)
• Sciton Er:YAG Laser PROFILE 3000 (K040005)

Submission Summary (Full Text)

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052806 1 of 3
OCT 17 2005

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# 510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

# 1. General Information

Submitter:

WaveLight Laser Technologie, AG Am Wolfsmantel 5 91058 Erlangen Germany

Contact Person:

Alexander Popp Am Wolfsmantel 5 91058 Erlangen Germany Telephone: [phone] Fax: [phone]

Summary Preparation Date:

- 2. Names
Device Name:

Classification Name:

BURANE

July 30, 2004

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

# 3. Predicate Devices

The BURANE 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 CO3 Er:YAG Laser (K983034), the Laserscope Laser VELA (K971843), the WaveLight BURANE XL (K050317) and the Sciton Er:YAG Laser PROFILE 3000 (K040005).

# 4. Device Description

BURANE is a Er:YAG laser system for dermatological interventions and for aesthetic laser applications. The BURANE has an Ablation Mode and a Coagulation Mode.

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# 510(k) Summary of Safety and Effectiveness

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Furthermore, the laser system enables a quick, precise ablation with minimal r arthernore, the lamage. Thus an optimal wound healing process is achieved thornial toous admission is minimized. This is due to the BURANE's wavelength of 2.94 µm, which has an absorption maximum in water and is wavelong. I of Elect pery well by tissue water. The thermal damage zone is thus minimized.

While the parameter wavelength is specified by the device, spot size, laser energy, pulse sequence, and coagulation function can be selected by the treating physician for optimal adjustment to individual requirements.

# 5. Indications for Use

The BURANE is indicated:

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, Ismoh 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 Surgery

Skin resurfacing and treatment of wrinkles.

# Dermatology/Plastic Surgery

Indications include, epidermal nevi, telangiectasia, spider veins, actinic incheditis, 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.

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K052806 3 of 3

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# 510(k) Summary of Safety and Effectiveness

# Genitourinary

Genitourinaly
Indications include lesions of the external genitalia, urethra and anus, penis, Indications include tesions of the extransmate, giant perineal scrotum and urethra (Includes contylema actinoma), vulvar lesions, polyps and familial polyps of the colon.

#### Gynecology

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

#### ENT

Indications include ear, nose and throat lesions, polyps, cysts, mulcations include our, noos ania and the sue, 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

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

- 6. Performance Data
None presented.

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Public Health Service

OCT 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wavelight Laser Technologie AG c/o Jeffrey D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive, P.O. Box 13995 Research Triangle Park, North Carolina 27709-3995

Re: K052806

Trade/Device Name: BURANE 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: August 29, 2005 Received: October 4, 2005

Dear Mr. Rongero:

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 complics 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Jeffrey D. Rongero

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,

Mark N. Mullen

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K052806

WaveLight®

# 510 {k} Indications for Use

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Indications for Use

510(k) Number (if known): N/A BURANE Device Name:

Indications for Use:

The BURANE is intended to be used in small and large joint arthroscopy, taparoscopic procedures, general and all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and inololokolori, Tapes encountered in all surgical procedures are included in cantiage. An Soft tissue, oncentraneous tissue, subcutaneous tissue, straited and this indication odor as, chari, satamoniscus, mucous membrane, lymph vessels smooth tissue, massio, caraids. The BURANE is indicated for use in skin and frodoo, organo and glansend for use in medicine and surgery, in the following medical specialities: Dermatology, Plastic 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 cheilitis, mulcatoris mondo, oplaamaanal 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 The L. . FO laser to intonebal to the reserv application where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial tresection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation.

#### Genitourinary

Indications include lesions of the external genitalia, urethra and anus, penis, Indications frolude foolone of the additional acuminate, giant perineal condyloma servicing and arothing (ona), vulvar lesions, polyps and familial polyps of the colon.

#### Gynecology

510(k) N

Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adjhesions, cysts and condyloma.

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

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Jumber_ 405 2806

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K052806

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# S WaveLight®

# 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 gingivectomy.

# Ophtalmology

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

# Podiatrv

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

Over-The-Counter Use N/A Prescription Use V AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorative, and Neurological Devices

510(k) Num! rr_k os Z &O(z

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