SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01

K990568 · Synergetics, Inc. · GEX · May 14, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990568
• Device Name: SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.01
• Applicant: Synergetics, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synergetics Inc., Mode Scrambled LindoOto Laser Probe provides a means of delivering photocoagulation during otologic surgery. Indications include, but are not limited to treatment of stapes related disorders to be treated with stapedectorny by means of photocoagulation. This device transmits laser energy to target tissuc, thereby causing photocoagulation. Spot size can be varied by altering the distance between the tissuc and the probe tip.

Device Story

The Mode Scrambled EndoOto Laser Probe is a surgical instrument used by otolaryngologists during otologic procedures. It functions as a delivery system for laser energy, enabling photocoagulation of target tissues. The device is operated by a surgeon in an operating room setting. By adjusting the distance between the probe tip and the target tissue, the surgeon can vary the laser spot size to achieve the desired clinical effect. This allows for precise tissue treatment during stapedectomy and other otologic surgeries, potentially improving surgical outcomes by providing controlled energy delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a laser probe designed for the transmission of laser energy to target tissues. It features a variable spot size mechanism controlled by the distance between the probe tip and the tissue. It is classified as a Class II device (Product Code: GEX).

Indications for Use

Indicated for patients undergoing otologic surgery, specifically for the treatment of stapes-related disorders via stapedectomy using photocoagulation.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 1999

Mr. Kurt Gampp Vice President Synergetics, Inc. 88 Hubble Drive St. Charles, Missouri 63304-8694

K990568 Re: Trade Name: Mode Scrambled EndoOto Laser Probe Regulatory Class: II Product Code: GEX Dated: February 19, 1999 Received: February 23, 1999

Dear Mr. Gampp:

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 Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 - Mr. Kurt Gampp

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 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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Section XII - Indications for Use Statement

## Intended Use: A.

The Synergetics Inc., Mode Scrambled LindoOto Laser Probe provides a means of delivering photocoagulation during otologic surgery. Indications include, but are not limited to treatment of stapes related disorders to be treated with stapedectorny by means of photocoagulation. This device transmits laser energy to target tissuc, thereby causing photocoagulation. Spot size can be varied by altering the distance between the tissuc and the probe tip.

Prescription Use
(Per 21 CFR 801.109) X

Oeeeto

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Division of General Restorative Devices K990568
510(k) Number