INNOVAQUARTZ GENERAL SHAPE LASER FIBER

K994010 · Innovaquartz · GEX · Dec 17, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K994010
• Device Name: INNOVAQUARTZ GENERAL SHAPE LASER FIBER
• Applicant: Innovaquartz
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InnovaQuartz General Shape Laser Fiber is indicated for use in the vaporization, coagulation, hemostasis and incision of soft tissue. It is designed for use with ND: Yag laser systems, HO: Yag laser systems or Argon laser systems which have been cleared for medical use and accept SMA 905 connectors.

Device Story

InnovaQuartz General Shape Laser Fiber acts as a delivery conduit for laser energy; transmits light from ND:Yag, HO:Yag, or Argon laser systems to target soft tissue. Used by physicians in clinical settings for surgical procedures including vaporization, coagulation, hemostasis, and incision. Device connects to laser consoles via standard SMA 905 interface. Fiber facilitates precise energy delivery to tissue, enabling controlled surgical outcomes. Benefits include versatility across multiple laser modalities and compatibility with existing surgical laser infrastructure.

Clinical Evidence

Bench testing only.

Technological Characteristics

Optical fiber delivery system; SMA 905 connector interface; compatible with ND:Yag, HO:Yag, and Argon laser systems. Passive device; no software or electronic components.

Indications for Use

Indicated for soft tissue vaporization, coagulation, hemostasis, and incision. Intended for use with cleared ND:Yag, HO:Yag, or Argon laser systems equipped with SMA 905 connectors.

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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DEC 1 7 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Randy McClellan Quality Assurance and Regulatory Affairs Manager InnovaOuartz, Inc. 4420 South 32nd Street Phoenix, Arizona 85040

K994010 Re: Trade Name: InnovaQuartz General Shape Laser Fiber Regulatory Class: II Product Code: GEX Dated: November 23, 1999 Received: November 26, 1999

Dear Mr. McClellan:

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 (OS) 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 _ Mr. Randy McClellan

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,

Kinnell Jayson

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

Enclosure

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## Attachment 2

## Indications for Use Statement

210(k) K99 401 V Number Device Name InnovaQuartz General Shape Laser Fiber Indications for The InnovaQuartz General Shape Laser Fiber is indicated for use in the vaporization, Use coagulation, hemostasis and incision of soft tissue. It is designed for use with ND: Yag laser systems, HO: Yag laser systems or Argon laser systems which have been cleared for medical use and accept SMA 905 connectors.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rasseli ligone

(Division Sign-Off) Division of General Resy, 510(K) Number ________________________________________________________________________________________________________________________________________________________________