The Revolix Duo continuous wave 2.01 micron laser system 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, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

The Revolix Duo pulsed Holmium 2.1 micron laser system 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 and hard tissue in use in medical specialties including: Urnlogy, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

Device Description

The RevoLix Duo is a combination of a diode pump solid state laser operating at a wavelength of 2.01 micron and a pulsed flashlamp Holmium laser operating at 2.1 microns. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery 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 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 text is a 510(k) Summary for the Revolix Duo Laser System (K070466). Due to the nature of 510(k) submissions for Class II medical devices like surgical lasers, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than performing a de novo clinical study with explicit acceptance criteria for device performance.

Therefore, the input document does not contain the detailed information requested regarding acceptance criteria, a specific study proving the device meets those criteria, test set sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, ground truth types for test sets, training set sizes, or how training set ground truth was established.

Instead, the "study" proving the device meets acceptance criteria (via substantial equivalence) is the comparison to predicate devices.

Here's a breakdown of why the requested information is absent and what the document does provide:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for a new device. The "acceptance criteria" here are implicitly that the Revolix Duo Laser System performs equally well or similarly enough to the predicate devices for the specified indications for use, without raising new questions of safety and effectiveness.

Reported Device Performance: Not presented as a distinct performance evaluation from a clinical trial. The "performance" is considered equivalent to that of the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices (Lisa Laser RevoLix continuous wave 2 micron laser and Lisa Laser Sphinx 80 Watt Holmium Laser (K070466)) for stated Indications for Use.	The Revolix Duo Laser System was found to be substantially equivalent to the predicate devices for its intended use and indications for use.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable. This document does not describe a clinical performance study with a distinct "test set" of patient data.
Data Provenance: Not applicable. The submission relies on the established safety and effectiveness of the predicate devices, not on new clinical data from the Revolix Duo system itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no mention of a test set with expert-established ground truth.

4. Adjudication method for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a laser surgical instrument, not an AI diagnostic device that would typically involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is not an algorithm, it's a physical surgical laser system that requires a human operator. Its performance is inherent to its physical operation, not an algorithm's output.

7. The type of ground truth used:

Not applicable in the context of a new performance study. The "ground truth" for the submission is the regulatory precedent set by the predicate devices.

8. The sample size for the training set:

Not applicable. This device does not use machine learning, so there is no training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

{0}------------------------------------------------

K070466

Attachment V

510(k) Summary

APR 1 7 2007

1.General Information

Submitter:	AllMed Systems Inc.9232 Klemetson DrivePleasanton CA 94588
Phone:	925-468-0433
Fax:	925-399-5984
Contact Person	Peter Allen
Date Prepared	16th February 2007

1. Names

Device Name	Revolix Duo Laser System
Common Name	2.01micron and 2.1 micron Laser System
Classification Name	Laser Surgical Instrument and accessories

3. Predicate Device

Lisa Laser Products – RevoLix Continous Wave 2 micron Laser Lisa Laser Products - Sphinx 80 Watt Holmium Laser System

4. Product Description

{1}------------------------------------------------

It consists of:

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

5. Indications for Use

Continuous Wave 2.01 micron Laser

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 Hyperplasia (BHP).

Transurethral incision of the prostate (TUIP)

Holmium Laser Resection of the Prostrate (HoLRP)

Holmium Laser Enuculeation of the Prostate (HoLEP)

Holmium laser Ablation of the Prostate (HoLAP)

Condylomas

Lesions of external genitalia

Gasteroenterlogy

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

Appendectomy Polyps Biopsv Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy

{2}------------------------------------------------

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 Granuloma Palliation of obstructing carcinoma of the tracheobroncial tree

Gynecology

Open and faparoscopic 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 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 or laryngeal Tonsillectomy Adenoidectomy

{3}------------------------------------------------

Dermatology and Plastic Surgery

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 Tonsillectomv 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

{4}------------------------------------------------

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

Holmium Laser pulsed 2.1 micron

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) Holmium Laser Resection of the Prostrate (HoLRP) Holmium Laser Enuculeation of the Prostate (HoLEP) Holmium laser Ablation of the Prostate (HoLAP) Condvlomas Lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy

Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones.

Endoscopic fragmentation of kidney calculi

Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.

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

{5}------------------------------------------------

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 Esophaqitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions

Arthroscopy

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:

Ligament and tendon Release Contouring and sculpting of articular surfaces Capsulectomy in the Knee Chondreplasty in the Knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears Plica Removal Meniscectomy Loose Body Debridement Lateral retinecular release

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

Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Foraminoplasty

Percutaneous Cervical Disc Decompression/Discectomy

Percutaneous Thoracic Disc Decompression/Discectomy

Pulmonary

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

{6}------------------------------------------------

Gynecology

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

ENT

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

Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery

Dermatology and Plastic Surgery

Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas

General Surgery

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

Skin incision Excision of external and internal lesions Complete of partial resection of internal organs, tumors and lesions Biopsv

6. Rationale for Substantial Equivalence

The Revolix Duo laser system with fiber optic delivery devices share the same intended use, indications for use, similar design features and functional features and therefore are

{7}------------------------------------------------

substantially equivalent to the Lisa Laser Products RevoLix continuous wave 2 micron laser , and the Lisa Laser Products Sphinx 80 watt Holmium Laser

7. Conclusion

The Revolix Duo 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.

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K070466

Trade/Device Name: Revolix Duo 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: April 6, 2007 Received: April 9, 2007

APR 1 7 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 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.

{9}------------------------------------------------

Page 2 -- Mr. Peter Allen

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

Enclosure

{10}------------------------------------------------

510(k) Number:

Device Name: Revolix Duo

Indications For Use:

Continuous Wave 2.01 micron Laser

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 Hyperplasia (BHP),

Transurethral incision of the prostate (TUIP)

Holmium Laser Resection of the Prostrate (HoLRP)

Holmium Laser Enuculeation of the Prostate (HoLEP)

Holmium laser Ablation of the Prostate (HoLAP)

Condylomas

Lesions of external genitalia

Gasteroenterlogy

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

Appendectomy Polyps Biopsv

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 9

{11}------------------------------------------------

510(k) Number:

Device Name: Revolix Duo

Indications For Use:

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 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

Larvngeal Lesions Airway obstructions including carcinoma Polyps and Granuloma Palliation of obstructing carcinoma of the tracheobroncial tree

Prescription Use X (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 9

{12}------------------------------------------------

510(k) Number:

Device Name: Revolix Duo

Indications For Use:

Gynecology

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

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 antrostomv Functional endoscopic sinus surgery Lesions or tumors of the oral, nasal, glossal, pharyngeal or laryngeal Tonsillectomy Adenoidectomy

Dermatology and Plastic Surgery

Basal Cell Carcinomas Lesions of skin and subcutaneous tissue

AND/OR

Prescription Use X (Part 21 CFR 801 Subpart D) 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 9

{13}------------------------------------------------

510(k) Number:

Device Name: Revolix Duo

Indications For Use:

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

Prescription Use X (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 9

{14}------------------------------------------------

510(k) Number:

Device Name: Revolix Duo

Indications For Use:

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 Foraminoplastv

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

The Revolix Duo pulsed Holmium 2.1 micron laser system and its fiber optic delivery system are intended for use in surgical procedures using open, faparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

Holmium Laser pulsed 2.1 micron

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)

Holmium Laser Resection of the Prostrate (HoLRP)

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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 9

{15}------------------------------------------------

510(k) Number:

Device Name: Revolix Duo

Indications For Use:

Holmium Laser Enuculeation of the Prostate (HoLEP) Holmium laser Ablation of the Prostate (HoLAP) Condylomas Lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy

Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones.

Endoscopic fragmentation of kidney calculi

Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.

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 Ulcers Gastric ulcers Duodenai ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer

Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 6 of 9

{16}------------------------------------------------

510(k) Number:

Device Name: Revolix Duo

Indications For Use:

Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions

Arthroscopy

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:

Lateral retinecular release

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

Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Foraminoplasty

Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy

Prescription UseX_	AND/OR	Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)		(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 7 of 9

{17}------------------------------------------------

510(k) Number:

Device Name: Revolix Duo

Indications For Use:

Pulmonary

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

Gynecology

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

ENT

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

Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery

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 8 of 9

{18}------------------------------------------------

510(k) Number:

Device Name: Revolix Duo

Indications For Use:

Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas

General Surgery

Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete of partial resection of internal organs, tumors and lesions Biopsy

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

510(k) Number K070466

Prescription Use X (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 9 of 9

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.