The Revolix 120 laser systems and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy

Device Description

The RevoLix 120 laser system is diode pump solid state surgical laser system operating at a wavelength of 2.01 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic/laparoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch

AI/ML Overview

The provided 510(k) summary for the RevoLix 120 Laser System does not contain acceptance criteria or study data demonstrating the device meets such criteria.

The document is a premarket notification for substantial equivalence, which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This type of submission typically relies on a comparison of design, materials, and intended use to predicate devices, rather than new clinical trials or detailed performance acceptance criteria.

Therefore, I cannot provide the requested table and information as it is not present in the given text. The document focuses on:

Device identification and classification.
Identification of predicate devices: Lumenis/Coherent Medical - VersaPulse Ho:YAG 100 watt, Trimedyne Omnipulse Max 80 watt, RevoLix 90 watt.
Product description: Diode pump solid state surgical laser system operating at 2.01 micron for ablation, coagulation, dissection, and resection of soft tissue.
Indications for Use: Extensive list across various medical specialties (Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery, Arthroscopy).
Rationale for Substantial Equivalence: Stating the RevoLix 120 shares "the same intended use, indications for use, similar design features and functional features" with the Lumenis VersaPulse Laser.
Conclusion: The device was found substantially equivalent to predicate surgical laser systems.

In summary, none of the requested information regarding acceptance criteria, performance data, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies is available in this 510(k) submission. These details would typically be found in performance data sections of a 510(k) submission, clinical trial reports, or other regulatory filings, which are not included here.

Summary

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K070476

MAR 2 6 2007

Attachment V

510(k) Summary

1.General Information

Submitter:

AllMed Systems Inc. 9232 Klemetson Drive Pleasanton CA 94588
925-468-0433 Phone:

925-399-5984 Fax

Contact Person Peter Allen

15th February 2007 Date Prepared

1. Names

Device Name	Revolix 120 Laser System
Common Name	2.01micron Laser System
Classification Name	Laser Surgical Instrument and accessories

3. Predicate Device

Lumenis/Coherent Medical - VersaPulse Ho:YAG 100 watt Trimedyne Omnipulse Max 80 watt RevoLix 90 watt

4. Product Description

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It consists of:

Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch

5. Indications for Use

Urology

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors. Ablation of Benign Prostatic Hypertrophy (BHP), Transurethral incision of the prostate (TUIP) Laser Resection of the Prostrate (HoLRP) Laser Enuculeation of the Prostate (HoLEP) Laser Ablation of the Prostate (HoLAP) Condylomas Lesions of external genitalia

Gastroenterology

Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including:

Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias of the Osler-Weber-Renu disease

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Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions

Thoracic and Pulmonary

Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

Laryngeal Lesions Airway obstructions including carcinoma Polyps and Granulomas Palliation of obstructing carcinomas of the tracheobronchial tree

Gynecology

Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis)

Intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation and or vessel coagulation

Soft tissue excision procedures such as excisional conization of the cervix

ENT

Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including:

Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal Tonsillectomy Adenoidectomy

Dermatology and Plastic Surgery

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Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including:

Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts

General Surgery

Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Cholecystectomy Lysis of adhesion Appendectomy Biopsy Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs, tumors and lesions Mastectomy Hepatectomy Pancreatectomy Splenectomy Thyroidectomy Parathyroidectomy Herniorrhaphy Tonsillectomy Lymphadenectomy Partial Nephrectomy Pilonidal Cystectomy Resection of lipoma Debridement of Decubitus Ulcer Hemorrhoids Debridement of Statis Ulcer Biopsy

Arthroscopy

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)

Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including Percutaneous Laser Disc Decompression/Discectomy Foraminoplasty Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery.

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6. Rationale for Substantial Equivalence

The Revolix 120 laser system with fiber optic delivery devices share the same intended use, indications for use, similar design features and functional features and therefore are substantially equivalent to the Lumenis VersaPulse Laser

7. Conclusion

The Revolix 120 Laser System with fiber optic delivery devices were found to be substantially equivalent to similar currently marketed and predicate surgical laser systems and delivery devices.

દ્દ

(Division Sign-Off) Division of General, Restorative, and Neurol of General, Rest

510(k) Number K070476
K070476 POF

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol on the right, which is a staff with two snakes coiled around it. To the left of the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AllMed Systems Inc. % Mr. Peter Allen President 9232 Klemetson Drive Pleasanton, California 94588

MAR 2 6 2007

Re: K070476 Trade/Device Name: RevoLix 120 Laser 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 Product Code: GEX Dated: March 13, 2007 Received: March 14, 2007

Dear Mr. Allen:

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 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

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Page 2 - Mr. Peter Allen.

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 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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

Device Name: RevoLix 120 Laser System

Indications For Use:

Urology

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Urethral Strictures

Bladder Neck Incisions (BNI)

Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors.

Ablation of Benign Prostatic Hypertrophy (BHP),

Transurethral incision of the prostate (TUIP)

Laser Resection of the Prostrate (HoLRP)

Laser Enuculeation of the Prostate (HoLEP)

Laser Ablation of the Prostate (HoLAP)

Condylomas

Lesions of external genitalia

Gastroenterology

Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including:

Appendectomy Polyps Biopsv Gall Bladder calculi Biliary/Bile duct calculi

11 Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 5

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510(k) Number:

RevoLix 120 Laser System Device Name:

Indications For Use:

Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions

Thoracic and Pulmonary

Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

Laryngeal Lesions Airway obstructions including carcinoma Polyps and Granulomas · Palliation of obstructing carcinomas of the tracheobronchial tree

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 5

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510(k) Number:

Device Name: RevoLix 120 Laser System

Indications For Use:

Gynecology

Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis)

Intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation and or vessel coagulation Soft tissue excision procedures such as excisional conization of the cervix

ENT

Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including:

Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal Tonsillectomy Adenoidectomy

Dermatology and Plastic Surgery

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 3 of 5

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510(k) Number:

RevoLix 120 Laser System Device Name:

Indications For Use:

Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts

General Surgery

Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Prescription Use س (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 4 of 5

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510(k) Number:

Device Name: RevoLix 120 Laser System

Indications For Use:

Pilonidal Cystectomy Resection of lipoma Debridement of Decubitus Ulcer Hemorrhoids Debridement of Statis Ulcer Biopsy

Arthroscopy

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)

Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including

Percutaneous Laser Disc Decompression/Discectomy Foraminoplasty

Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery.

Prescription Use سا (Part 21 CFR 801 Subpart D)

AND/OR

. Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 5 of 5

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.