K Number

Device Name

REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200

Manufacturer

ALLMED SYSTEMS INC.

Date Cleared

2013-02-19

(687 days)

Product Code

GEX

Regulation Number

878.4810

Intended Use

The RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 laser systems and their 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 Family of diode pump solid state ( that include the RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200) are part of a family of surgical laser systems operating at a wavelength of 2.01 micron. The purpose of these lasers is to ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic surgical applications and procedures in an aqueous and non-aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a hand piece. endoscopic or laparoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

RevoLix Jr, RevoLix 120 watt, Quanta Cyber TM 150

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a surgical laser system and its components, focusing on its physical characteristics, intended uses, and performance testing. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

Yes
The device is a surgical laser system intended for use in various medical specialties to perform procedures like incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue, which are all therapeutic actions.

Diagnostic

The device is described as a "surgical laser system" intended for "ablation, coagulation, dissection and resection of soft tissue" in various surgical procedures. This functionality is therapeutic, not diagnostic.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "family of surgical laser systems" and lists hardware components such as a "Laser Console with Internal Computer Control Panel and Display," a "fiber optic delivery system," and a "Footswitch." This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes the device as a surgical laser system for procedures involving incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue within the body. This is a therapeutic and surgical application, not a diagnostic one performed in vitro (outside the body).
Device Description: The description details a surgical laser system with a fiber optic delivery system and handpiece, designed for direct interaction with tissue during surgery. This aligns with a surgical device, not an IVD which typically involves analyzing samples like blood, urine, or tissue in a laboratory setting.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or performing tests on specimens outside the body, which are hallmarks of IVD devices.

The device is a surgical laser system used for treating conditions by directly interacting with tissue.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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

Note: The RevoLix 160 and 200 are only approved for the treatment of BPH when used at power levels greater than 120 watts

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
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 coaqulation
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

Incision, excision, resection, ablation, vaporization, coaqulation and hemostasisof 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
Appendectomv
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.

Product codes

GEX

Device Description

The RevoLix Family of diode pump solid state ( that include the RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200) are part of a family of surgical laser systems operating at a wavelength of 2.01 micron. The purpose of these lasers is to ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic surgical applications and procedures in an aqueous and non-aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a hand piece. endoscopic or laparoscopic surgical instrument.
It consists of:
Laser Console with Internal Computer Control Panel and Display
A fiber optic delivery system
Footswitch

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Urethral, Bladder, Uretheral, Ureteral, Prostate, external genitalia, Appendix, Polyps, Gall Bladder, Biliary/Bile duct, Gastric, Duodenal, Pancreas, Hemorrhoids, Colorectal, Osler-Weber-Renu disease related vascular malformations, Esophagus, Colon, Mallory-Weiss tear affected areas, Larynx, Airway, Lungs, Tracheobronchial tree, Uterus, Cervix, Nose, Sinuses, Dacryocystorhinostomy affected areas, Frontal Sinus, Ethmoid bone, Maxillary bone, Oral cavity, Nasal cavity, Glossal area, Pharyngeal area, Laryngeal area, Tonsils, Adenoids, Skin, Subcutaneous tissue, Breast, Liver, Spleen, Thyroid, Parathyroid, Hernia site, Lymph nodes, Kidney, Pilonidal Cyst, Lipoma, Decubitus Ulcer affected areas, Statis Ulcer affected areas, Spinal tissues.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

All necessary bench testing was conducted on the proposed family of RevoLix lasers to support a determination of substantial equivalence to the predicate device. The depth of thermal injury and coagulation were measured and compared to the RevoLix 120 and did not show significant differences. The ablation depth was also measured and found to be of comparable depth, with an adjustment in the translation speed depended on the power level. Other tissue effects such as carbonization were also found to be comparable. All clinical data provided in this submission supporting the RevoLix 200 at a setting of 200 watts is provided ONLY for the indication of use in the treatment of BPH.

Key Metrics

Not Found

Predicate Device(s)

RevoLix Jr, RevoLix 120 watt, Quanta Cyber TM 150

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

FEB 1 9 2013

Attachment V

510(k) Summary

1.General Information

Submitter:

AllMed Systems Inc. 9232 Klemetson Drive Pleasanton CA 94588

24th March 2011

Phone: 925-468-0433

925-399-5984 Fax

Contact Person Peter Allen

Date Prepared

2. Names

| Device Name | Revolix Family of Laser Systems including the RevoLix Jr
30, RevoLix Jr 50 RevoLix 160 and RevoLix 200 |
|---------------------|-----------------------------------------------------------------------------------------------------------|
| Common Name | 2.01micron Laser System |
| Classification Name | Laser Surgical Instrument and accessories |

3. Predicate Device

RevoLix Jr, RevoLix 120 watt and Quanta Cyber TM 150

4. Product Description

It consists of:

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

5. Indications for Use

The RevoLix Jr 30, RevoLix 160 and RevoLix 200 laser systems and their 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

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

Note: The RevoLix 160 and 200 are only approved for the treatment of BPH when used at power levels greater than 120 watts

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 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

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 coaqulation

Soft tissue excision procedures such as excisional conization of the cervix

ENT

Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coaqulation 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 Surgerv

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 Appendectomv Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs, tumors and lesions Mastectomy Hepatectomy Pancreatectomv Splenectomv Thyroidectomy Parathyroidectomy Herniorrhaphy Tonsillectomy Lymphadenectomy Partial Nephrectomy Pilonidal Cystectomy Resection of lipoma Debridement of Decubitus Ulcer Hemorrhoids Debridement of Statis Ulcer Biopsv

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

6. Rationale for Substantial Equivalence

The Revolix Jr 30. RevoLix Jr 50. RevoLix 160 and RevoLix 200 laser systems and their 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 RevoLix Jr, RevoLix 120 and Quanta Cyber TM 150.

Testing and Clinical Evaluation.

7. Conclusion

The Revolix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 Laser Systems with fiber optic delivery devices was found to be safe and effective and therefore substantially equivalent to the predicate surgical laser systems and delivery devices.

Note: The RevoLix 160 and 200 are only approved for the treatment of BPH when used at power levels greater than 120 watts

Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

AllMed Systems, Incorporated % Mr. Peter Allen 495 Main Street Wilbraham, Massachusetts 01095

February 19, 2013

Re: K110941

Trade/Device Name: RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLiz 200 Regulation Number: 21 CFR 878.4810

Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulatory Class: Class II Product Code: GEX Dated: March 24, 2011 Received: December 31, 2012

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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

510(k) Number: K110941

Device Name: RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200

Indications For Use:

The Revolix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 laser systems and their 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

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

Note: The RevoLix 160 and 200 are only approved for the treatment of BPH when used at power levels greater than 120 watts

Neil R Ogden R 2013.02.15 15:28:29 :05 100'

for MXM (Division Sign-Off) Division of Surgical Devices 510(k) Number K110941

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 6

K110941 510(k) Number:

Device Name: RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200

Indications For Use:

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 Vascular Malformation Gastritis Esophagitis

Neil R Ogden= Neil R Ogden - 30:00 -05'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K110941 .

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 2 of 6

510(k) Number: K110941

Device Name: RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200

Indications For Use:

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

ﺮ

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 coaqulation

Soft tissue excision procedures such as excisional conization of the cervix

Neil R Ogdenz 2013.02.15 5 3 11-2 -05'00'

(Division Sian-Off) for MXM Division of Surgical Devices K110941 510(k) Number

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 6

K110941 510(k) Number:

Device Name: RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200

Indications For Use:

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

Neil R Ogdens 2013.02.15 1 32-19-05'00'

for MXM (Division Sign-Off) Division of Surgical Devices K110941 510(k) Number

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 4 of 6

510(k) Number: K110941

Device Name: RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200

Indications For Use:

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 Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs, tumors and lesions Mastectomv Hepatectomy

Neil R Ogder 33-26 -05'00' 2013.02.15 15

(Division Sign-Off) for MXM Division of Surgical Devices K110941 510(k) Number

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 5 of 6

510(k) Number: K110941

Device Name: RevoLix Jr 30, RevoLix Jr 50; RevoLix 160 and RevoLix 200

Indications For Use:

Pancreatectomy Splenectomy Thyroidectomy Parathvroidectomy 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 Foraminoplastv Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery.

Neil R Ogdens 2013.02.15 11:34:26 -05'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K110941

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 6 of 6