REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200 by ALLMED SYSTEMS INC.

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the RevoLix Family of Laser Systems:

It is important to note that the provided document is a 510(k) Summary for a medical device (laser surgical instrument), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims. As such, the information you've requested regarding specific acceptance criteria, sample sizes, expert qualifications, and ground truth for a study proving the device meets acceptance criteria (as would be found for a diagnostic AI device, for example) is largely not present in this type of submission.

The document describes bench testing to support substantial equivalence, but not a full-fledged clinical trial to establish quantitative performance against defined acceptance criteria in the way a diagnostic AI device would.

Acceptance Criteria and Reported Device Performance

Given the nature of the submission (510(k) for a surgical laser), the "acceptance criteria" are primarily related to demonstrating substantial equivalence to existing predicate devices in terms of intended use, indications for use, and functional features, and similar performance characteristics in bench testing. Performance is described qualitatively, rather than via quantitative metrics with defined thresholds like sensitivity, specificity, etc.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Intended Use: Surgical procedures for ablation, coagulation, dissection, and resection of soft tissue.	"The RevoLix Family... 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." (Page 1)
Indications for Use: Matching predicate device across various medical specialties (Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery, Arthroscopy).	Multiple pages (2-5, 8-13) detail extensive and identical indications for use across all listed specialties as the predicate device.
Wavelength: 2.01 micron.	"operating at a wavelength of 2.01 micron." (Page 1)
Delivery Method: Fiber optic delivery system through handpiece, endoscopic, or laparoscopic instruments.	"The laser power is delivered via standard silica laser fibers. The distal tip is guided by a hand piece. endoscopic or laparoscopic surgical instrument." (Page 1)
Similar Design and Functional Features: Comparable to predicate devices.	"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." (Page 6)
Depth of Thermal Injury and Coagulation: Not significantly different from predicate device.	"The depth of thermal injury and coagulation were measured and compared to the RevoLix 120 and did not show significant differences." (Page 6)
Ablation Depth: Comparable to predicate device, with adjustment for translation speed based on power level.	"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." (Page 6)
Other Tissue Effects (e.g., carbonization): Comparable to predicate device.	"Other tissue effects such as carbonization were also found to be comparable." (Page 6)
Safety and Effectiveness: "Safe and effective" determination based on substantial equivalence.	"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." (Page 6)

Study Details (Based on the provided 510(k) Summary)

Sample size used for the test set and the data provenance:
- The document mentions "All necessary bench testing was conducted on the proposed family of RevoLix lasers." It does not specify the sample size (e.g., number of tissue samples, animals, or human subjects) used for these bench tests.
- Data provenance: "Bench testing" generally refers to in-vitro or ex-vivo testing in a laboratory setting, not patient data. No specific country of origin is mentioned, but typically such testing would occur in the manufacturer's R&D facilities or contracted labs. The testing appears to be "prospective" in the sense that it was performed specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For physical performance testing of a laser, "ground truth" would likely be established by objective measurements (e.g., using calibrated instruments for depth, temperature, visual assessment of tissue effects) rather than expert consensus on interpretive data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for evaluating the interpretation of medical images or diagnostic outputs, where subjective assessment by multiple readers is required. For bench testing of a laser's physical effects, objective measurement and comparison to specifications or predicate device performance are the primary methods.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is a key component. This submission is for a surgical laser, where the primary function is direct tissue interaction, not aiding human readers in interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical laser system, which is inherently a human-in-the-loop device (a surgeon operates it). It is not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the bench testing would be objective physical measurements (e.g., direct measurement of thermal injury depth, ablation depth, observation of tissue effects like carbonization) and comparison to the known performance of the predicate device. Pathology or outcomes data would be part of clinical trials, which are beyond the scope of this 510(k) summary focused on substantial equivalence via bench testing.
The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm requiring a training set with ground truth.

Summary of what the document does provide regarding the "study" (bench testing):

The "study" refers to bench testing performed on the RevoLix family of lasers. This testing aimed to demonstrate that the new devices perform in a "comparable" manner to the predicate device in terms of direct tissue effects. The key findings were:

Depth of thermal injury and coagulation: No "significant differences" when compared to the RevoLix 120 (predicate).
Ablation depth: "Comparable depth" with an adjustment in translation speed.
Other tissue effects (e.g., carbonization): "Comparable."

This information supports the claim of substantial equivalence, which is the core requirement for a 510(k) clearance, rather than establishing novel quantitative performance metrics for a diagnostic or AI device.

Summary

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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 Jr30, 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

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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

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

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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

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Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal . Tonsillectomy Adenoidectomy

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Dermatology and Plastic Surgerv

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 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

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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.

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.

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

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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

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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.

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

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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

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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

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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

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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

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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

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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

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.