OPTILITE IX LASER SURGERY ACCESSORIES

K992866 · Convergent Laser Technologies · GEX · Nov 18, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992866
• Device Name: OPTILITE IX LASER SURGERY ACCESSORIES
• Applicant: Convergent Laser Technologies
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OptiLITE IX Laser Surgery Accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd: YAG, Argon, Diode, Ho:YAG, and Er:YAG wavelengths for the indications for which the lasers have been cleared.

Device Story

OptiLITE IX Laser Surgery Accessories are fiber-optic delivery devices designed to attach to cleared surgical laser systems (KTP, Nd:YAG, Argon, Diode, Ho:YAG, Er:YAG). These accessories transmit laser energy from the host system to the surgical site to perform incision, excision, ablation, and coagulation. Used in clinical/OR settings by physicians. The device acts as a passive conduit for laser energy; clinical decision-making relies on the host laser system's parameters and the surgeon's technique. Benefits include precise tissue interaction for various surgical applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fiber-optic laser delivery accessories. Compatible with KTP, Nd:YAG, Argon, Diode, Ho:YAG, and Er:YAG laser wavelengths. Passive delivery system; no internal energy source or software.

Indications for Use

Indicated for incision, excision, ablation, and coagulation in surgical procedures when used with cleared KTP, Nd:YAG, Argon, Diode, Ho:YAG, and Er:YAG laser systems. Patient population is defined by the indications of the host laser system.

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1999

Marilyn Chou. Ph.D. Executive Vice President Convergent Laser Technologies 900 Alice Street Oakland, California 94607

Re: K992866

> Trade Name: OptiLITE IX Laser Surgery Accessories Regulatory Class: II Product Code: GEX Dated: August 24, 1999 Received: August 25, 1999

Dear Dr. Chou:

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 - Marilyn M. Chou. Ph.D.

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,

Russell L. Raynor

James E. Dillard III Sur Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number : K 992866

Devicc Name: OptiLITE IX Laser Surgery Accessories

Indications For Use:

The OptiLITE IX Laser Surgery Accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd: YAG, Argon, Diode, Ho:YAG, and Er:YAG wavelengths for the indications for which the lasers have becn cleared.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Remell/Roza 80520

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992866

| Prescription Use | <span></span> X |
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OR

Over-The-Counter Use _

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(21 CFR 801.109)