CERALAS 980NM DIODE LASER FAMILY

K112324 · Biolitec Medical Devices, Inc. · GEX · Sep 6, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K112324
• Device Name: CERALAS 980NM DIODE LASER FAMILY
• Applicant: Biolitec Medical Devices, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ceralas Fiber Coupled 980nm 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.

Device Story

Ceralas 980nm Diode Laser family delivers optical energy via fiber-coupled accessories for soft tissue surgical procedures. Device functions as surgical laser for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation. Used in open or closed endoscopic applications across multiple surgical specialties. Operated by physicians in clinical/surgical settings. Output is laser energy applied to tissue; effect is thermal tissue interaction. Benefits include precise tissue management and hemostasis during surgery.

Clinical Evidence

Bench testing only. Device complies with voluntary consensus standards including 21 C.F.R. §§ 1040.10 & 1040.11, ANSI/AAMI ES1, IEC 601-2-22, EN 60825-1, and ANSI/AAMI/ISO 10993-7.

Technological Characteristics

980nm diode laser system; fiber-coupled delivery accessories. Identical to predicate. Complies with 21 C.F.R. §§ 1040.10 & 1040.11, ANSI/AAMI ES1, IEC 601-2-22, EN 60825-1, and ANSI/AAMI/ISO 10993-7.

Indications for Use

Indicated for soft tissue surgery including incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation. Applicable across general surgery, urology, gynecology, gastroenterology, otolaryngology, plastic surgery, dermatology, podiatry, neurosurgery/peripheral, pulmonary surgery, arthroscopy, cardiothoracic surgery, laser-assisted lipolysis, ophthalmology, dental applications, and endovenous occlusion of the greater saphenous vein.

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 980nm Diode Laser Family (covering models: D15, D25, D50, E15, & E30; D100, D120, D150 & D180)

Submission Summary (Full Text)

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K 112324

# SEP - 6 2011

#### 510(k) Summary Ceralas 980nm Diode Laser Family

#### 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 10, 2011

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

Ceralas 980nm Diode Laser Family Biolitec Medical Devices, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

### Classification Name

Surgical laser & accessories

## Predicate Devices

Ceralas 980nm Diode Laser Family (covering models: D15, D25, D50, E15, & E30; D100, D120, D150 & D180)

# Intended Use/Indication for Use

The Ceralas Fiber Coupled 980nm 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.

# Technological Characteristics

イ

The Ceralas 980nm 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 980nm 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 601-2-22; EN 60825-1, and ANSI/AAMI/ISO 10993-7.

#### Substantial Equivalence

The Biolitec Medical Devices Inc Ceralas 980nm family is as safe and effective as the Biolitec Inc. Ceralas 980nm family as the products are identical in all aspects except labeling relating to the manufacturer/ distributor.

The Ceralas 980nm family has the same intended uses, indications, technological characteristics, and principles of operation as its predicate devices. Thus, the Ceralas 980nm family from Biolitec Medical Devices, Inc. is substantially equivalent to its predicate devices from Biolitec, Inc.

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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 caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

Biolitec Medical Devices, Inc. % Harry Hayes. Ph.D. 515 Shaker Road East Longmeadow, Massachusetts 01028

Re: K112324

Frade/Device Name: Ceralas Fiber Coupled Diode Laser Family 980mm (covering 980nm Models: D15. D25. D50. E15 & E30; D100, D120, D150 & D180) 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: August 10, 2011 Received: August 12, 2011

Dear Dr. Hayes:

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.

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Page 2 - Harry Hayes, Ph.D.

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); 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/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/ReportalProblem/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 yours,

Mark A. Millerson

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

510(k) Number (if known): K112324

Device Name:

Ceralas Fiber-Coupled Diode Laser Family 980nm (covering 980nm Models: D15, D25, D50, E15, & E30; D100, D120, D150 & D180)

Indications for Use:

The Ceralas Fiber Coupled 980nm 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. Indications include: General Surgery, Urology,

Gynecology, Gastroenterology, Otolaryngology, Plastic Surgery, Dermatology, Podiatry, Neurosurgery/ Peripheral. Pulmonary Surgery, Arthroscopy, Cardiothoracic Surgery, Laser Assisted Lipolysis. Ophthalmology, Dental Applications, Endovenous Occlusion of the Greater Saphenous Vein.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|------------------------------------------------------|---------------------------------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Surgical, Orthopedic, |
| | and Restorative Devices |
| Prescription Use <u>✓</u><br>(Per 21 C.F.R. 801.109) | 510(k) Number <u>L112329</u><br>Over The Counter Use ____<br>(Optional Format 1-2-96) |

GBDA/ BioMD-980-081011-03