The Laser Ix Diode Laser System is intended for delivery of laser light to soft tissue in contact or non contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Laser Ix laser system is generally indicated for incision, excision Vaporization, ablation, hemostatis or coagulation of soft tissue In Ear, Nose and Throat and Oral surgery (Otolaryngology), Dental Procedures, Arthroscopy Gastroenterology, General Surgery, Dermatology Plastic surgery, Podiatry, Urology, Gynecology, Neurosurgery (Peripheral nervous system) Pulmonary surgery and cardiothoracic surgery. The Laser Tx Diode laser system can be used with fiber optic laser delivery devices and photosensitizing agents & chromophores to enhance target tissue effects and photo selective application during surgical procedures. The LaserTx Diode Laser system is indicated for incision, excision, vaporization, hemostatis coagulation, ablation of soft tissue, tumors, strictures, obstructions in body organs including urethra, bladder, prostate, uterus, breast, stomach, colon, abdomen, veins lung, brain, ear, nose throat etc. For additional indications for use please refer to attachment. (Additional Indications, identical to predicated device cleared by FDA under 510K application # K032864)

Device Description

LaserTx™ - Diode Laser & Delivery System

AI/ML Overview

The provided text is a 510(k) clearance letter for a medical device called the LaserTx™ - Diode Laser & Delivery System. This document primarily focuses on establishing substantial equivalence to a predicate device and outlining the intended uses and indications for the device.

It does not contain information about acceptance criteria, device performance metrics, clinical study design (sample size, data provenance, ground truth establishment, adjudication methods), or multi-reader multi-case comparative effectiveness studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information regarding the study design elements you specified based solely on this document. The document confirms that the device is cleared for marketing based on its substantial equivalence to an existing predicate device, but it does not detail the specific performance validation data for the current device.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ProSurg, Inc. c/o Mr. Ashvin Desai Manager, Regulatory Affairs 2195 Trade Zone Boulevard San Jose. CA 95131

Re: K060326

Trade/Device Name: LaserTx™ - Diode Laser & Delivery System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: OCL, GEX Dated: February 2, 2006 Received: February 15, 2006

Dear Mr. Desai:

This letter corrects our substantially equivalent letter of April 5, 2006.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (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 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.

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Page 2 - Mr. Ashvin Desai

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.

This letter will allow you to continue 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

ellmpell

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K060326

Device Name: LaserTx™ - Laser & Delivery System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative,
and Neurological Devices

file://F:\indicate.html	3/31/2006
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510(k) Number	K060326
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510 (k) NUMBER (IF KNOWN) : K 060326

DEVICE NAME: LaserTxTM - Diode Laser & Delivery System

INDICATIONS FOR USE:

The device is specifically indicated for use as follows:

Ear, Nose and Throat and Oral Surgery (Otolaryngology)

Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:

Removal of benign lesions from the ear, nose and throat す
Excision and vaporization of vocal cord nodules and polyps
Incision and excision of carcinoma in situ
Ablation and vaporization of hyperkeratosis
Excision of carcinoma of the larynx
Laryngeal papillomectomy
Excision and vaporization of herpes simplex I and II
Neck dissection ◆

Arthroscopy

Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:

Menisectomy .
Synovectomy ◆
Chondromalacia ◀

Gastroenterology

Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:

Hemostasis of upper and lower GI bleeding
Excision and vaporization of colorectal carcitioners
Excision of polyps

gmee

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

K060326 510(k) Number_

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General Surgery, Dermatology, Plastic Surgery and Podiatry

Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:

Matrixectomy �
Excision of neuromas ▲ Excision of periungual and subungual warts
Excision of plantar warts
Excision of keloids 4
Liver resection �
Excision of cutaneous lesions .
Hemorrhoidectomy .
Appendectomy .
Debridement of decubitus ulcers 4
Hepatobiliary tumors 사
Mastectomy 한
Dermabrasion 해
Vaporization and homeostasis of capillary hemangioma ♥
Excision, vaporization and hemostasis of abdominal tumors
Excision, vaporization and hemostasis of rectal pathology
Pilonidal cystectomy .
Herniorapphy .
Adhesiolysis �
Parathyroidectomy
Laparoscopic cholecystectomy
Thyroidectomy
Resection of organs
Debridement of wounds �
Phototcoagulation of teleangectasia of the legs and face
Photocoagulation of vascular lesions of the face and ◆ extremities
Endovascular coagulation of the greater saphenous vein of � the thigh in patients with superficial vein reflux.
Treatment of reticular veins and branch varicosities .

Urology

Excision, vaporization, incision, coagulation, ablation and homeostasis of urological tissues. Examples include:

Vaporization of urethral tumors ●
Release of urethral stricture .
Removal of bladder neck obstruction
Excision and vaporization of condyloma
Lesions of external genitalia

Division Sign-Off) >ivision of General, Restorative,

ad Neurological Devices

4060326 10(k) Number.

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Gynecology

Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:

Endometrial ablation .
Excision or vaporization of condylomata acuminata .

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Vaporization of cervical intraepithelial neoplasia 0
Cervical conization .
Menorrhagia .

Neurosurgery

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: homeostasis in conjunction with menigiomas

Cardiac Surgery

Hemostasis and coagulation of soft tissue, including cardiac tissue. Pulmonary Surgery

Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:

Tracheobronchial malignancy or stricture ◆
Benign and malignant pulmonary obstruction
Endoscopic pulmonary applications

Dental Applications

Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectory, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux

Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

Prescription Use X (Part 21 C.F.R. 801 Subpart D).

elmaee

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

510(k) Number_ 406032 6

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.