ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX

K023257 · Prosurg, Inc. · GEX · Mar 28, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023257
• Device Name: ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX
• Applicant: Prosurg, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Endoscopic Laser Delivery System -LaserTx with diffuser -tip fiberoptic delivery catheter is indicated for general tissue coagulation & ablation during general surgery, general grological, general gynecological and general gastroenterological procedures , and Endoscopic laser coagulation of turnors , fibroids and other soft tissue. The Endoscopic Laser Delivery System -Laser Tx with bare -tip fiberoptic is indicated for the incision, excision, and ablation or coagulation of tissues with hemostatis during general surgery, and general gastroenterological and urological procedures.

Device Story

Endoscopic Laser Delivery System - LaserTx; fiberoptic delivery catheter system. Inputs: laser energy delivered via diffuser-tip or bare-tip fiberoptic catheters. Operation: delivery of laser energy to target tissue for coagulation, ablation, incision, or excision. Used in clinical settings (OR/endoscopy) by physicians. Output: thermal energy effect on soft tissue; achieves hemostasis. Benefits: minimally invasive surgical access for tumor/fibroid treatment and general soft tissue management.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Fiberoptic delivery system; includes diffuser-tip and bare-tip catheter configurations. Energy source: laser (external). Intended for endoscopic and general surgical applications. No software or electronic control circuitry described.

Indications for Use

Indicated for patients undergoing general surgery, urological, gynecological, and gastroenterological procedures requiring tissue coagulation, ablation, incision, or excision, including treatment of tumors and fibroids.

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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Public Health Service

MAR 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ashvin Desai Manager, Regulatory Affairs ProSurg, Inc. 2193 Trade Zone Boulevard San Jose, California 95131

Re: K023257

Trade Name: Endoscopic Laser Delivery System - LaserTx 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: January 3, 2003 Received: January 9. 2003

Dear Mr. Desai:

We have reviewed your Section 510(k) premarket 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) 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. Desai

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]. 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 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,

uriam 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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NUMBER (IF KNOWN) : K023257 510 (k) DEVICE NAME : Endoscopic Laser_delivery System-Lasertx INDICATIONS FOR USE:

## Indications For Use:

## Endoscopic Laser Delivery System -LaserTx

The Endoscopic Laser Delivery System -LaserTx with diffuser -tip fiberoptic delivery catheter is indicated for general tissue coagulation & ablation during general surgery, general grological, general gynecological and general gastroenterological procedures , and Endoscopic laser coagulation of turnors , fibroids and other soft tissue.

The Endoscopic Laser Delivery System -Laser Tx with bare -tip fiberoptic is indicated for the incision, excision, and ablation or coagulation of tissues with hemostatis during general surgery, and general gastroenterological and urological procedures.

(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) Over-The-Counter-Use (Optional Format 1-2-96)

Miriam C. Provost

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

K02325 510(k) Number __