MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE

K013193 · Biolitec, Inc. · GEX · Dec 21, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K013193
• Device Name: MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
• Applicant: Biolitec, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The company's MegaBeam/Ceralas NonSterile Collimating Handpiece is intended to be used as a fiber optic delivery accessory to a laser device. Please refer to the Laser User Manual for a complete list of indications.

Device Story

MegaBeam/Ceralas Non-Sterile Collimating Handpiece functions as a fiber optic delivery accessory for surgical laser systems. Device consists of 3-meter quartz optical fiber housed in anodized aluminum handpiece; integrated lenses collimate laser beam to produce 7mm spot size. Operated by clinicians in surgical or dermatological settings to deliver laser energy to target tissue. Output characteristics include specific beam divergence and energy density profiles. Device serves as conduit for laser energy; clinical decision-making relies on primary laser system parameters; handpiece facilitates precise energy delivery to patient.

Clinical Evidence

Bench testing only. Biolitec compared handpiece efficiency, energy density, and divergent half-angle against MegaBeam Bare Fiber. Results demonstrate the device is as safe and effective as the predicate.

Technological Characteristics

3-meter quartz optical fiber; anodized aluminum handpiece; integrated collimating lenses; 7mm spot size output. Non-sterile. Passive optical delivery accessory.

Indications for Use

Indicated for use as a fiber optic delivery accessory for laser devices in general and plastic surgery and dermatology. Not for endoscopic applications.

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 MegaBeam Sterile Fiber optic Delivery System's Bare Fibers
• Coherent VersaSpot & Collimated Handpiece
• Coherent Ultrafine TrueSpot Collimating Handpiece

Submission Summary (Full Text)

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K 013193

DEC 21 2001

# 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 Morello, V.M.D. Date prepared: September 24, 2001

## Name of Device and Name/Address of Sponsor

MegaBeam/Ceralas Non Sterile Collimating Handpiece Biolitec. Inc. 515 Shaker Road East Longmeadow, MA 01028

Classification Name

Accessory to Surgical Laser Instrument

#### Predicate Device

Biolitec Inc MegaBeam Sterile Fiber optic Delivery System's Bare Fibers Coherent VersaSpot & Collimated Handpiece Coherent Ultrafine TrueSpot Collimating Handpiece

#### Intended Use

The company's MegaBeam/Ceralas Non Sterile Collimating Handpiece is intended to be used as a fiber optic delivery accessory to a laser device. Please refer to the Laser User Manual for complete list of indications.

# Technological Characteristics and Substantial Equivalence

The Mega Beam/Ceralas Collimating Handpiece consists of a 3 meter quartz optical fiber encased in an anodized aluminum handpiece. The aluminum handpiece has lenses that collimate the beam to create a 7mm beam and resulting 7mm spot size. The MegaBeam/Ceralas Collimating Handpiece maximum power output was less than the predicate devices and its divergence angle is less than the predicate. However, these technological differences do not raise any new questions of safety and effectiveness, as demonstrated by the performance data.

## Performance Data

Biolitec conducted testing comparing the MegaBeam/Ceralas Collimating Handpiece's and the MegaBeam Bare Fiber's handpiece efficiency, energy density and divergent half angle. These

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performance tests demonstrate that the MegaBeam /Ceralas Collimating Handpiece is as safe and effective as the Fiber Optic Delivery System's Bare Fiber.

## Substantial Equivalencies

The MegaBeam/Ceralas Collimating Handpiece has the same intended use as all three of its predicate devices, the same indications as one of the predicate devices, except that it cannot be used in endoscopic applications, and very similar principles of operation as the predicate collimating handpieces and similar technical characteristics as a combination of the predicate devices. The minor technical differences between the MegaBeam/Ceralas Collimating Handpiece and its predicate devices do not raise new questions of safety or effectiveness. Performance data Demonstrates that the MegaBeam/Ceralas Collimating Handpiece is as safe and effective as its predicate device. Thus, the MegaBeam/Ceralas Collimating Handpiece is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 21 2001

Carol J. Morello, V.M.D. Manager of Regulatory Affairs Biolitec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

Re: K013193

Trade/Device Name: MegaBeam/Ceralas Non-Sterile Collimating Handpiece Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 24, 2001 Received: September 24, 2001

Dear Dr. Morello:

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 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.

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Page 2 - Carol J. Morello, V.M.D.

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,

Ata Hytk Rhode
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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Indications for Use Form K 013193 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: Mega Beam/Ceralas Nonsterile Collimating Handpiece

Indications for Use:

The company's MegaBeam/Ceralas NonSterile Collimating Handpiece is intended to be used as a fiber optic delivery accessory to a laser device. Please refer to the Laser User Manual for a complete list of indications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styph Rworde

vision of General, Restorative and Neurological Devices

510(k) Number K013193

న Prescription Use _ (Per 21 C.F.R. 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)