BWF-5 MEDICAL LASER SERIES

K093087 · Litecure, LLC · GEX · May 12, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093087
• Device Name: BWF-5 MEDICAL LASER SERIES
• Applicant: Litecure, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The BWF-5 Medical Laser Series (810nm, 930nm, 980nm, 1080nm and 1320nm) are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery. The device is specifically indicated for use as follows: LASER 980nm: Indicated for use with the VARI-LASE Procedure Kit in the Endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux. LASER 1320nm: Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.

Device Story

Compact medical laser system; delivers laser light via flexible optical fiber to soft tissue in contact or non-contact modes. Operator enables laser via foot switch; touch-screen panel adjusts output levels. Operates in continuous wave or controlled pulse modes. Used in clinical/surgical settings by physicians for incision, excision, vaporization, ablation, hemostasis, or coagulation. Specific endovascular applications require VARI-LASE Procedure Kit. Output allows precise tissue interaction; benefits include controlled surgical outcomes and minimally invasive vein treatment.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and performance standards compliance.

Technological Characteristics

Compact laser system; wavelengths 810nm, 930nm, 980nm, 1080nm, 1320nm. Flexible optical fiber delivery. Touch-screen interface. Continuous wave or controlled pulse modes. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.

Indications for Use

Indicated for soft tissue incision, excision, vaporization, ablation, hemostasis, or coagulation in various surgical specialties including ENT, dental, arthroscopy, GI, general, derm, plastic, podiatry, urology, GYN, neuro, pulmonary, and thoracic surgery. Specifically indicated for endovascular coagulation of the Greater Saphenous Vein in patients with superficial vein reflux (980nm) and treatment of reflux of great saphenous veins associated with varicose veins (1320nm).

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

• INTERmedic Diode Laser Family (K053540)
• Biolitec, Inc., Ceralas E 980nm Diode Laser (K082263)
• QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY (K083613)
• BioTex, Inc., PhoTex 15 Diode Laser Series (K060304)
• Laserscope, 800 Series Surgical Laser System (K972575)
• B&W Tek, Inc., BWF-5 Medical Laser Series (K062363)
• Sciton, Inc., Profile Multi-Platform System (K060033)
• Biolitec, Inc., 100W CERALAS D 980NM DIODE LASER (K071295)
• Sciton, Inc., Profile Multi-Platform System (K070388)

Submission Summary (Full Text)

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# MAY 1 2 2010

1693087

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# 510(k) SUMMARY

The Summary of Safety and Effectiveness on the LiteCure, LLC BWF-5 Medical Laser Series reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.

| Applicant | LiteCure, LLC<br>250 Corporate Blvd., Suite B<br>Newark, Delaware 19702<br>Tel: [phone] |
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| Date | April 02, 2010 |
| Correspondent | Liang Lu, Regulatory Affairs Manager |
| Device Name | BWF-5 Medical Laser Series |
| Classification | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology, 21 CFR 878.4810 |
| Predicate Device | K053540 INTERmedic Arfran, S.A., INTERmedic Diode Laser<br>Family 810 nm and 980 nm and the delivery accessories that are used<br>with them to deliver, ultrasound and RF Surgical 15TM, 30TM, 50TM,<br>100TM, 120TM and SR 15 OFTTM, MULTIDIODE PL3DTM,<br>ContrAgeTM, RF ContrAgeTM,MULTIDIODE VARIUSTM, VR1000TM,<br>MULTIDIODE ODONTTM; K082263 Biolitec, Inc., Ceralas E 980nm Diode Laser (Models<br>E15/980, E30/980); K083613 QUANTA SYSTEM POLYSURGE DIODE LASER<br>FAMILY; K060304 BioTex, Inc., PhoTex 15 Diode Laser Series: 810, 940, 980,<br>market clearance date March 21, 2006; and K972575 Laserscope, 800 Series Surgical Laser System Orion<br>Surgical Laser System Angled Delivery Devices (ADD Family<br>Product Line), market clearance date July 17, 1998. K062363 B&W Tek, Inc., BWF-5 Medical Laser Series. K060033 Sciton, Inc., Profile Multi-Platform System. K071295 Biolitec, Inc., 100W CERALAS D 980NM DIODE LASER K070388 Sciton, Inc., Profile Multi-Platform System |
| Intended Use | The BWF-5 Medical Laser Series (810nm, 930nm, 980nm, 1080nm<br>and 1320nm) are intended for delivery of laser light to soft tissue in the<br>contact or non-contact mode during surgical procedures, including via<br>endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are<br>generally indicated for incision, excision, vaporization, ablation,<br>hemostasis or coagulation of soft tissue in ear, nose and throat and oral<br>surgery (otolaryngology), dental procedures, arthroscopy,<br>gastroenterology, general surgery, dermatology, plastic surgery, podiatry,<br>urology, gynecology, neurosurgery (peripheral nervous system),<br>pulmonary surgery and thoracic surgery. The device is specifically<br>indicated for use as follows: |
| Intended Use<br>(continued) | LASER 980nm:<br>Indicated for use with the VARI-LASE Procedure Kit in the Endovascular<br>coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients<br>with Superficial Vein Reflux.<br><br>LASER 1320nm:<br>Indicated for use with the VARI-LASE Procedure Kit in the treatment of<br>reflux of great saphenous veins associated with varicose veins and<br>varicosities. |
| Description | BWF-5 Medical Laser Series are compact medical laser systems. The laser<br>light delivery system consists of a flexible optical fiber. Activation occurs<br>when the operator enables the laser and presses the foot switch. Release<br>the foot switch to deactivate the laser. Depending on laser system<br>configuration, the foot switch can function as on/off switch. A touch-<br>screen display panel allows the operator to adjust or set laser output level.<br>The laser can operate in continuous wave mode or controlled pulse mode. |
| Technological<br>Characteristics<br>and Substantial<br>Equivalence | The BWF-5 Medical Laser Series is as safe and effective as the predicate<br>devices. The BWF-5 Medical Laser Series has the same intended uses and<br>similar indications, technological characteristics (such as wavelength, laser<br>safety class, etc), and principles of operation as its predicate device. The<br>minor technological differences between the BWF-5 Medical Laser Series<br>and its predicate devices raise no new issues of safety or effectiveness.<br>Thus, the BWF-5 Medical Laser Series is substantially equivalent to its<br>predicate devices. |
| Compliance | 21 C.F.R. § 1040.10 & 1040.11 Performance Standards for Light Emitting Products;<br>IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety,<br>1988; Amendment 1, 1991-11, Amendment 2, 1995 (2nd Edition);<br>IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety<br>- Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition<br>2:2001 with Amendment 1:2004);<br>IEC 60601-2-22 1995, 2nd Edition, "Medical electrical equipment - Part 2: Particular<br>requirements for the safety of diagnostic and therapeutic laser equipment"<br>IEC 60825-1 Ed. 2.0 (2007), Safety of laser products - Part 1: Equipment classification,<br>and requirements. |

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### 510(k) SUMMARY continued

The Summary of Safety and Effectiveness on the LiteCure, LLC BWF-5 Medical Laser Series reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned to the right of a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

LiteCure, LLC % Intertek Testing Services Mr. Jay Y. Kogoma 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

MAY 1 2 2010

Re: K093087

Trade/Device Name: BWF-5 Medical Laser Series Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and Plastic surgery and in dermatology Regulatory Class: Class II

Product Code: GEX Dated: May 05, 2010 Received: May 07, 2010

Dear Mr. Kogoma:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 does 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

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Page 2 - Mr. Jay Y. Kogoma

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely vours.

Sincerely yours,

Mark A. Milliken

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name

Indications For Use:

The BWF-5 Medical Laser Series (810nm, 930nm, 1080mm and 1320nm) are intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The BWF-5 Medical Laser Series are generally indicated for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery and thoracic surgery.

The device is specifically indicated for use as follows:

#### LASER 980nm:

Indicated for use with the VARI-LASE Procedure Kit in the Endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

#### LASER 1320nm:

Indicated for use with the VARI-LASE Procedure Kit in the treatment of reflux of great saphenous veins associated with varicose veins and varicosities.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Oyler for mxm
(Digital Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093087