15W CERALAS D 1470NM DIODE LASER, MODEL D1470

K082225 · Biolitec, Inc. · GEX · Dec 3, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082225
• Device Name: 15W CERALAS D 1470NM DIODE LASER, MODEL D1470
• Applicant: Biolitec, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 3, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

Device Story

15W Ceralas D 1470nm Diode Laser delivers laser light to soft tissue in non-contact mode; used for treatment of saphenous vein reflux associated with varicose veins. Device includes ELVeS Kit for vascular access. Operated by clinicians in surgical settings. Laser energy targets soft tissue to treat venous insufficiency. Benefits include minimally invasive treatment of varicosities.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological comparison to predicate devices.

Technological Characteristics

1470nm diode laser system; non-contact delivery mode; includes ELVeS Kit for vascular access; 15W power output.

Indications for Use

Indicated for treatment of reflux of saphenous veins associated with varicose veins and varicosities in patients requiring soft tissue general surgery procedures.

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

• Biolitec, Inc.'s 15W Ceralas D 1470nm Diode Laser (Model D1470)
• Cool Touch CTEV 1320 Nd: YAG Laser (K043046, K051434, K061618, K062210)

Submission Summary (Full Text)

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082225
510(k) SUMMARY

## Biolitec's Ceralas D1470

DEC 0 3 2008

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

> Hogan & Hartson 555 Thirteenth St. NW Washington DC 20004

Phone: [phone] Facsimile: 202-637-5910

Contact Person: Jonathan S. Kahan

Date Prepared: August, 2008

# Name of Device and Name/Address of Sponsor

15W Ceralas D 1470nm Diode Laser (Model D1470)

Biolitec. Inc. 515 Shaker Road East Longmeadow, MA 01028

## Common or Usual Name

Diode Laser

## Classification Name

Laser, Surgical Diode Laser System

## Predicate Devices

Biolitec, Inc.'s 15W Ceralas D 1470nm Diode Laser (Model D1470) Cool Touch CTEV 1320 Nd: YAG Laser (K043046,K051434, K061618 and K062210)

## Purpose of the Special 510(k) notice.

The Ceralas D1470 is a modification to Biolitec's previously cleared Ceralas D1470.

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## Intended Use / Indications for Use

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The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities

## Technological Characteristics

The Ceralas D1470 has substantially similar technological characteristics as compared to the previously cleared Ceralas D1470. The Ceralas D1470 contains an ELVeS Kit for gaining access to the vasculature to treat varicose veins and varicosities associated with superficial reflux of the saphenous veins.

## Substantial Equivalence

The Ceralas D1470 is as safe and effective as the cleared Ceralas D1470 and the Cool Touch CTEV laser. The Ceralas 1470 has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Ceralas D1470 and its predicate device raises no new issues of safety or effectiveness. Thus, the Ceralas D1470 is substantially equivalent.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biolitec. Inc. % Hogan & Hartson, LLP Mr. Johnathan S. Kahan 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

DEC 0 3 2008

Re: K082225

Trade/Device Name: 15W Ceralas D 1470nm Diode Laser (Model D1470) 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: November 13, 2008 Received: November 13, 2008

Dear Mr. Kahan:

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 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 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

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Page 2 - Mr. Johnathan S. Kahan

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 M. Milliman

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

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# Indications for Use Statement

510(k) Number (if known):

Device Name: 15W Ceralas D 1470nm Diode Laser (Model D1470)

Indications for Use:

The Ceralas D1470 is a diode laser that is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

Prescription Use X (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Oyler for mxm

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

**510(k) Number** K082225

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