BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100

K030959 · Laser Peripherals, LLC · GEX · Apr 25, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030959
• Device Name: BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100
• Applicant: Laser Peripherals, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 25, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Laser Peripherals bare laser fiber is intended for use in laser surgical procedures for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, KTP and Diode lasers have been cleared.

Device Story

Laser Peripherals Bare Laser Fiber is a surgical accessory used to deliver laser energy to soft tissue. Device functions as a conduit for Nd:YAG, KTP, and Diode laser systems; enables cutting, coagulation, or vaporization of soft tissue during surgical procedures. Operated by physicians in clinical or surgical settings. Device serves as an interface between the laser source and the patient's tissue; facilitates precise energy delivery for surgical intervention. Benefits include versatility across multiple laser wavelengths and soft tissue applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bare laser fiber optic delivery system; compatible with Nd:YAG, KTP, and Diode laser wavelengths. Designed for soft tissue surgical applications (cutting, coagulation, vaporization).

Indications for Use

Indicated for use in soft tissue surgical procedures including cutting, coagulating, or vaporizing, utilizing compatible Nd:YAG, KTP, and Diode lasers.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

APR 2 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeffrey M. Stein Research & Development Manager Laser Peripherals LLC 1000 Boone Avenue North, Suite 300 Golden Valley, Minnesota 55427

Re: K030959

Trade/Device Name: Laser Peripherals Bare Laser Fiber 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: March 25, 2003 Received: March 27, 2003

Dear Mr. Stein:

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 (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. Jeffrey M. Stein

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), 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) you may obtain. 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,

Miriam C. Provost

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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## ATTACHMENT B

## Indications for Use Statement

510(k) Number:

K 030959

Device Name:

Laser Peripherals Bare Laser Fiber

Indications

For Use:

The Laser Peripherals bare laser fiber is intended for use in laser surgical procedures for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, KTP and Diode lasers have been cleared.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

:

OR

Over-The-Counter Use

Muriam C. Provost

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

K030959 510(k) Number -