CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60

K020835 · Biolitec, Inc. · GEX · Jun 12, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020835
• Device Name: CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60
• Applicant: Biolitec, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

In addition to the Ceralas D 10-60 810 nm Diode Laser System's previously-cleared indications, this device is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Device Story

Ceralas D10-60 Diode Laser System is a surgical laser used for endovascular coagulation of the greater saphenous vein. Device operates at 810nm wavelength with power output ranging from 1-60W in continuous wave (CW) or pulsed modes. Used by clinicians in a surgical setting to treat superficial vein reflux. Laser energy is delivered to the target vein to induce coagulation. System is substantially equivalent to previously cleared Biolitec Ceralas D10-60 and Diomed 810nm surgical lasers.

Technological Characteristics

Diode laser system; 810nm wavelength; 1-60W power output; CW or pulsed operation modes.

Indications for Use

Indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

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

• Diomed 810nm Surgical Laser
• Biolitec Ceralas D10-60 810nm Diode Laser

Submission Summary (Full Text)

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020835 1/2

JUN 1 2 2002

## 510(k) Summary Ceralas Diode Laser System

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

Biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 [phone] Phone: Facsimile: [phone]

Contact Person: Carol J. Morello, V.M.D. Date prepared: March 7, 2002

# Name of Device and Name/Address of Sponsor

Ceralas Diode Laser System (Model D10-60) Biolitec, Inc. 515 Shaker Road East Longmeadow, MA 01028

#### Classification Name

Surgical laser

#### Predicate Device

Diomed 810nm Surgical Laser Biolitec Ceralas D10-60 810nm Diode Laser

#### Intended Use / Indications For Use

In addition to the already cleared indications for use: For use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

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020835 2/2

## Technological Characteristics

The Ceralas D10-60 Diode Laser and the predicate devices operate with a power range of 1-60W in the CW or pulsed mode.

### Substantial Equivalence

The new Ceralas D10-60 has the exact same intended use as the cleared Ceralas D10-60 and the Diomed Laser and the same indications as the combination of Ceralas D10-60 and Diomed Laser. The new Ceralas D10-60 also have the same technological characteristics as the cleared Ceralas D10-60 and very similar technological characteristics as the Diomed Laser. The minor technological differences between the new Ceralas D10-60 and the Diomed Laser raise no new questions of safety or effectiveness. Thus, the new Ceralas D10-60 is substantially equivalent.

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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines above them that could represent hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 2 2002

Biolitec. Inc. c/o Mr. Jonathan S. Kahan Hogan & Hartson 555 Thirteenth Street, N. W. Washington, D.C. 20004-1109

Re: K020835

Trade Name: Ceralas D10-60 810 Diode Laser System and ELVS Procedure Kit Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX Dated: February 27, 2002 Received: March 14, 2002

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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 – Mr. Jonathan Kahan

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Stupt Plurde
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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- cc:
- HFZ-404 510(k) Staff .
- HFZ-410 DGRND

. D.O

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. 510(k) Number (if known):_K O 20 8 3)

Device Name: Ceralas D 10-60 810 nm Diode Laser System

Indications for Use:

In addition to the Ceralas D 10-60 810 nm Diode Laser System's previously-cleared indications, this device is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hypt Plurds

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

510(k) Number K020835

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

OR

Over-The-Counter Use_

(Optional Format 1-2-96)