SCATTERFREE LATERAL EMITTING FIBER

K992083 · Laser Peripherals, LLC · GEX · Jul 12, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992083
• Device Name: SCATTERFREE LATERAL EMITTING FIBER
• Applicant: Laser Peripherals, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 12, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ScatterFree™ Lateral Emitting Fiber is intended for use in General, Urological, OB-GYN, Orthopedic and ENT laser surgical procedures for cutting, vaporizing or coagulating in any soft tissue application for which compatible Nd:YAG, KTP and Ho:YAG lasers have been cleared.

Device Story

ScatterFree™ Lateral Emitting Fiber; optical fiber delivery system for laser energy; transmits laser light from compatible Nd:YAG, KTP, or Ho:YAG surgical lasers to target soft tissue; used in OR settings by surgeons; enables cutting, vaporizing, or coagulating tissue; lateral emission design; provides controlled energy delivery for surgical procedures; benefits include precise tissue interaction and reduced collateral damage.

Clinical Evidence

Bench testing only.

Technological Characteristics

Lateral emitting optical fiber; compatible with Nd:YAG, KTP, and Ho:YAG laser wavelengths; designed for soft tissue surgical applications; passive delivery device; no software or electronic components.

Indications for Use

Indicated for patients undergoing soft tissue laser surgical procedures in General, Urological, OB-GYN, Orthopedic, and ENT specialties using compatible Nd:YAG, KTP, or Ho:YAG 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1.2 1999

Ms. Nancy L. Arnold President Laser Peripherals, Inc. 5484 Feltl Road Minnetonka, Minnesota 55343

Re: K992083

> Trade Name: ScatterFree™ Lateral Emitting Fiber Regulatory Class: II Product Code: GEX Dated: June 18, 1999 Received: June 21, 1999

Dear Ms. Arnold:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Nancy L. Arnold

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia B. Fisher, Ph.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT B

## Indications for Use Statement

992083

510(k) Number

ScatterFree™ Lateral Emitting Fiber Device Name

The ScatterFree™ Lateral Emitting Fiber is intended for use in Indications General, Urological, OB-GYN, Orthopedic and ENT laser surgical For Use procedures for cutting, vaporizing or coagulating in any soft tissue application for which compatible Nd:YAG, KTP and Ho:YAG lasers have been cleared.

## PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | X |
|---------------------------------------|----------------------|
| | OR |
| | Over-The-Counter Use |

(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | K992083 |
|---------------|---------|
|---------------|---------|