CERALAS 147NM DIODE LASER SYSTEM

K112253 · Biolitec, Inc. · GEX · Sep 20, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K112253
• Device Name: CERALAS 147NM DIODE LASER SYSTEM
• Applicant: Biolitec, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ceralas 1470nm Fiber-Coupled Diode Laser family (and its delivery accessories used to deliver optical energy) is indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities. Laser Assisted Lipolysis.

Device Story

Ceralas 1470nm Diode Laser system delivers optical energy via fiber-coupled delivery accessories to soft tissue. Used in general surgical, endoscopic, and dermatological applications; operated by physicians in clinical settings. Device performs incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation. Also indicated for endovenous occlusion of saphenous veins and laser-assisted lipolysis. System provides controlled thermal energy to target tissues; clinical benefit includes precise tissue management and minimally invasive treatment of venous conditions and adipose tissue.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical technological characteristics and performance to predicate devices.

Technological Characteristics

1470nm diode laser system; fiber-coupled delivery. Complies with 21 C.F.R. §§ 1040.10 & 1040.11, ANSI/AAMI ES1, IEC 601-1, IEC 601-2-22, EN 60825-1, and ANSI/AAMI/ISO 10993-7. Identical to predicate devices.

Indications for Use

Indicated for patients with superficial vein reflux associated with varicose veins and varicosities requiring endovenous occlusion, and patients requiring soft tissue incision, excision, ablation, cutting, vaporization, hemostasis, or coagulation, including laser-assisted lipolysis.

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

• Ceralas 1470nm Diode Laser System (K073063)
• Ceralas 1470nm Diode Laser System (K082225)
• Ceralas 1470nm Diode Laser System (K102755)

Submission Summary (Full Text)

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SEP 2 0 2011

# 510(k) Summary Ceralas 1470nm Diode Laser Family

KI12253

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

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

Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant Date prepared: August 3, 2011

### Name of Device and Name/Address of Sponsor

Ceralas 1470nm Diode Laser System Biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

#### Classification Name

Surgical laser

#### Predicate Devices

Ceralas 1470nm Diode Laser System, (K073063, K082225 and K102755).

#### Intended Use/Indication for Use

The Ceralas 1470nm Fiber-Coupled Diode Laser family (and its delivery accessories used to deliver optical energy) is indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated.

## Technological Characteristics

The Ceralas 1470nm family for Biolitec Medical Devices, Inc. is identical (contains the same components, technology and principles of operation and assembled by the same manufacturer) as the cleared Ceralas 1470nm family for Biolitec, Inc..

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#### Performance Data

The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-1; IEC 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7.

#### Substantial Equivalence

The Biolitec Medical Devices Inc Ceralas 1470nm family is as safe and effective as the Biolitec Inc. Ceralas 1470nm family as the products are identical in all aspects except labeling realating to the manufacturer/ distributor.

The Ceralas 1470nm family has the same intended uses, indications, technological characteristics, and principles of operation as its predicate devices. Thus, the Ceralas 1470nm family is substantially equivalent to its predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hamoshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20995-0002

Biolitec Medical Devices, Inc. % Genmarhav BDA Mr. Harry Haves 1349 Main Road Granville. Massachusetts 01034

SEP 20 2011

Re: K112253

Trade/Device Name: Ceralas 1470mm Diode Laser Family 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 3. 2011 Received: August 5, 2011

Dear Mr. Haves:

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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract hiability 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

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Page 2 - Mr. Harry Hayes

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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/CDRHQffices/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

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 Statement

112253 510(k) Number (if known): ----------------------

Device Name: Ceralas 1470nm Diode Laser Family

Indications for Use:

The Ceralas Fiber-Coupled 1470nm Diode Laser family (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated. Endovenous Occlusion of the Saphenous Veins in

Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities. Laser Assisted Lipolysis.

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

of CDRH, Office of Device Evaluation (ODE) Concurrenc MX m (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112253

Prescription Use __ V (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use_ (Optional Format 1-2-96)