CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM

K100726 · Biolitec, Inc. · GEX · Sep 15, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100726
• Device Name: CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM
• Applicant: Biolitec, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ceralas Fiber-Coupled Diode Laser family 980nm (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. Added Indication for Use: Percutaneous Lumbar Disc Decompression/ Diskectomy in soft and cartilaginous tissue.

Device Story

Ceralas Fiber-Coupled Diode Laser 980nm family delivers optical energy for soft tissue surgery. Device uses diode laser technology to perform incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation. Operated by physicians in clinical settings for open or closed endoscopic procedures. Output is laser energy delivered via fiber-coupled accessories. Clinical benefit includes precise tissue management and minimally invasive percutaneous lumbar disc decompression. Healthcare providers use the laser to achieve specific surgical outcomes through contact or non-contact tissue interaction.

Clinical Evidence

Bench testing only. Performance data demonstrates no significant difference in output or function compared to cleared predicate devices (Ceralas G15 532nm and D1950).

Technological Characteristics

Fiber-coupled diode laser system; 980nm wavelength; Class II device (21 CFR 878.4810). System includes various models (D15, D25, D50, E15, E30, HPD series). Energy source is diode laser; delivery via optical fiber accessories. Designed for contact/non-contact soft tissue application.

Indications for Use

Indicated for patients requiring soft tissue surgery (incision, excision, ablation, cutting, vaporization, hemostasis, coagulation) in open or closed endoscopic applications, and for percutaneous lumbar disc decompression/diskectomy in soft and cartilaginous tissue.

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 50W Ceralas D1950 (K072682)
• Ceralas G15 532 Frequency Doubled Nd:Yag (K002296)
• Quanta System Polysurge Diode Laser Family (K083613)
• Quanta System Diode Medical Laser Family (K072034)
• INTERmedic Diode Laser family 810nm & 980nm (K053540)

Submission Summary (Full Text)

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## 510(k) SUMMARY: K100726 Biolitec Inc.'s Ceralas Fiber-Coupled Diode Laser 980nm Family for an Additional Indication of Use

## Submitter's Name, Facility/ Manufacturing Address, Telephone/ Fax Number, Contact Person:

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

**SEP 1, 5 2010**

Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant, Biolitec Inc. - cell: [phone] Email: [e-mail] Or Nancy Foley - Manager of Regulatory Affairs, Biolitec Inc. Email: [e-mail]

Date Prepared: March 8, 2010

#### i. Name of Device and Name/ Address of Sponsor/ Establishment Reg. Number:

Ceralas Fiber-Coupled Diode Laser 980 nm Family

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

Establishment Registration Number: 1222625

ii. Common or Usual Name: Diode Laser

iii. Classification Name:

Laser, Surgical Diode Laser System

Classification Panel: iv.

The General Surgery Devices Branch has classified Diode Lasers as Class II devices pursuant to 21 C.F.R. § 878.4810

#### v. Predicate Devices:

Ceralas 50W Ceralas D1950 (K072682) Ceralas G15 532 Frequency Doubled Nd:Yag (K002296) Quanta System Polysurge Diode Laser Family (K083613) Quanta System Diode Medical Laser Family (K072034) INTERmedic Diode Laser family 810nm & 980nm (K053540)

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#### Intended Use/ Indications for Use vi.

The Ceralas Fiber-Coupled Diode Laser family 980nm (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.

Added Indication for Use:

Percutaneous Lumbar Disc Decompression/ Diskectomy in soft and cartilaginous tissue.

#### vii. Technological Characteristics

The Ceralas 980nm family have substantially similar technological characteristics as compared to the Ceralas G15 532nm Frequency-Doubled Nd:YAG laser and the Ceralas D1950 laser, as well as the Quanta System Polysurge 808nm, 980nm & 1950nm laser family, Quanta System Model 30 (808nm & 940nm) laser family and the INTERmedic 810nm & 980nm family.

#### viii. Performance Data

Performance testing of the Ceralas 980nm family demonstrates no significant difference as compared to the cleared Ceralas G15 532nm Frequency-Doubled Nd:YAG and D1950 lasers.

#### ix. Substantial Equivalence

The Ceralas 980nm family is as safe and effective for this additional Indication for Use as the Ceralas G15 532nm Frequency-Doubled Nd:YAG and D1950 lasers, the Quanta System Polysurge 808nm, 980nm & 1950nm laser family, the Quanta System Model 30 (808nm & 940nm) laser family and the INTERmedic 810nm & 980nm laser family.

The Ceralas 980nm family 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 980nm family and its predicate device raises no new issues of safety or effectiveness. Thus, the Ceralas 980nm family is substantially equivalent.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

SEP 1 5 2010

Biolitec, Inc. % Genmarhay BDA Harry Hayes, Ph.D. 1349 Main Road Granville, Massachusetts 01034

Re: K100726

Trade/Device Name: Ceralas Fiber-Coupled Diode Laser 980nm Family 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: September 07, 2010 Received: September 09, 2010

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 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/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 yours,

Mark N. Melkerson

Mark N. Melkers 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

The Company's Indications for Use Statement for the Device is provided below.

### · Indications for Use Statement:

510(k) Number (if known): K100726. Device Name:

Indications for Use:

Ceralas Fiber-Coupled Diode Laser Family 980nm (Covering 980nm Models: D15, D25, D50, E15, & E30; HPD100, HPD120, HPD150 & HPD180)

The Ceralas Fiber-Coupled Diode Laser family 980nm (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.

Added Indication for Use:

Percutaneous Lumbar Disc Decompression/ Diskectomy in soft and cartilaginous tissue.

Prescription Use ----X ---(Part 21 C.F.R. 801 Subpart D)

And/ Or

Over-The-Counter Use ---------(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)

Nil R. Reuber
(Division Plan Offi. for mxm

Division of Surgical, Cithopedic, and Restorative Devices

510(k) Number K100726