The Patriot 1 Family of Lasers, 400, 600 and 1000 micron sterile, disposable, single use fibers are indicated for incision, excision, resection, ablation, vaporization and coagulation of soft tissue encountered in urology, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery general surgery and arthroscopy.

Device Description

General Description- Thulium Laser/ Patriot 1 family of lasers. The U. S. Laser Worx Family of lasers are surgical instrument for use in general and plastic surgery and in dermatology (GEX). The Patriot 1 Family of lasers are installed with a single Tm:Fiber Laser Source with CW emission at 1.94 microns with adjustable power from 5 W to the maximum output power (as given below). The laser radiation is delivered to the tissue to be treated through fiber optics. The Patriot 1 Family (that includes 120, 150, 180 and the 200) and its accessories are intended for use in surqical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coaqulation 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.

AI/ML Overview

The provided document is a 510(k) summary for the U.S. Laser Worx Patriot 1 Family of Lasers. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results to meet specific performance acceptance criteria. Therefore, the document primarily details the device's specifications and how it compares to predicate devices, but does not contain the acceptance criteria or a study proving the device meets them in the format usually associated with clinical performance studies for AI/software devices.

However, based on the information provided, here's what can be extracted and inferred regarding the closest equivalents to "acceptance criteria" and "study":

The "acceptance criteria" in this context are implicitly that the U.S. Laser Worx Patriot 1 Family of Lasers is substantially equivalent to the predicate devices in terms of its intended use, design, performance, and safety. There are no explicit quantitative performance metrics or thresholds stated as acceptance criteria that a study would directly "prove" the device meets.

The "study" that proves the device meets this "acceptance criteria" is the Substantial Equivalence Summary and the Non-Clinical Performance Data presented. This is not a human-in-the-loop, standalone, or MRMC study in the context of AI/software for diagnostic tasks. Instead, it's a comparative analysis against predicate devices and adherence to safety standards.

Here's the breakdown of the information requested, based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Substantial Equivalence to Predicate Devices: - Similar laser medium (Tm:Fiber) - Similar wavelength - Similar power to tissue range - Similar operating modes (at least Continuous) - Similar beam delivery options (fiber sizes) - Similar aiming beam functionality - Adherence to electrical supply requirements - Similar cooling mechanism - Comparable dimensions and weight (within reasonable manufacturing variations) - Same intended uses/indications for use	Device is Substantially Equivalent: - Laser Medium: Tm:Fiber (Matches predicates) - Wavelength: 1.94 microns (Similar to 2.01 microns of predicates) - Power to Tissue: 5 to 120, 150, 180, and 200 Watts (Comparable to and encompasses predicate ranges) - Operating Modes: Continuous (One predicate offers only continuous; others offer continuous and pulsed, but the applicant's device is noted to be "CW" for pulsed mode - which implies continuous wave, suggesting pulsed capabilities weren't deemed necessary for equivalence or were handled differently) - Beam Delivery: 400, 600, 1000 micron fibers, specialty fibers (Comparable to predicates, with some minor differences in specific fiber sizes offered) - Aiming Beam: 450 nm Blue Diode, adjustable (Different wavelength/color than predicates' 635 nm Red Diode, but performs the same function) - Electrical Supply: 230 VAC, 30 Amps, 50/60 Hz (Comparable to predicates) - Cooling: Closed cycle, internal (Matches predicates) - Dimensions: H: 35.3", W: 19.8", L: 29.3" (Comparable to predicates) - Weight: TBD Pounds (Not yet finalized, but assumed to be within comparable range) - Indications for Use: Matches the broad range of soft tissue procedures across multiple specialties of the predicate devices.
Safety Standards Adherence: - Compliance with relevant IEC safety standards.	Safety Standards Met: - IEC 60601-1 ED 3.1(2012) - IEC 60601-1-2:2014 4th Ed - IEC 60601-2-22 Ed 3.1(2012) - IEC 60601-1:2005 - IEC 60601-1 ED3 (2007) AMENDMENT 1(2013) - IEC 60601-14(2014) —CANADA - IEC 60825-1 2007
Performance Verification: - Verification of power, measurements, software accuracy, and energy transmission.	Numerous Bench Tests Conducted: - Power verifications - Measurements - Accuracy of software - Energy transmission

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not applicable in the context of this 510(k). The "test set" here refers to the comparisons made against predicate devices' specifications on paper, along with non-clinical bench testing. There is no patient-based or image-based test set as would be seen in an AI performance study.
Data Provenance: Not applicable. The document describes the device's technical specifications and compares them to predicate devices, along with listing safety standards adhered to. There is no "data" in the sense of patient records, images, or clinical outcomes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This is a laser surgical instrument, and the submission focuses on engineering specifications and intended use comparison, not diagnostic performance requiring expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" that would require adjudication in this context.

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

No, an MRMC comparative effectiveness study was not done. This device is a surgical laser, not an AI diagnostic tool involving human readers.

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

Not applicable. This device is a physical surgical laser, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established specifications, intended uses, and safety standards of the predicate devices, as well as internationally recognized electrical and laser safety standards. There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the typical sense of a clinical trial for an AI/diagnostic device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/machine learning device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

Public Health Service

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

April 27, 2017

U.S. Laser Worx Frank Ford CEO 13423 Blanco Rd #162 San Antonio, Texas 78216

Re: K162334

Trade/Device Name: U.S. Laser Worx Patriot 1 Family of Lasers 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: February 9, 2017 Received: February 13, 2017

Dear Mr. Ford:

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. 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

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K162334

Device Name: Patriot 1 Family of Lasers and Accessories

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. 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

Prescription Use: X AND/OR Over the Counter Use: (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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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

AND/OR Over the Counter Use: Prescription Use: X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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Thoracic and Pulmonary

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

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, coaqulation 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 Tonsillectomv Adenoidectomy

Prescription Use: X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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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

Prescription Use: X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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General Surgery

Open laparoscopic and endoscopic surgery (incision, excision, 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 AND/OR Over the Counter Use: (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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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

Note: The Patriot 1 180 and 200 are only cleared for BPH when using over 150 W

Prescription Use: __ X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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510K SUMMARY

Title:	U. S. Laser Worx, Inc. Patriot 1 Family of Lasers and Accessories
Submitter:	U. S. Laser Worx, Inc.
Contact:	Timothy J. Shea189 Winding Oaks LaneOviedo, FL 32765Phone: 407-590-2050Email: tsheabo@aol.com
Date Prepared:	August 6, 2016
Device Trade Name:	Patriot 1 Family of Lasers and Accessories
Common Name:	Tm:Fiber Laser
Classification Name	21 CFR Part 878.4810Laser Surgical instrument for use in general and plastic surgery as well asDermatology
Predicate Devices:	AllMed Systems, Inc. Revolix 120 (K07046) and the Quanta System CyberTm 120, Tm 150, Tm 180 and the Tm 200 (K131081)
Review Panel:	General and Plastic Surgery (GEX)
PRODUCT CODE:	GEX
Device Description:	General Description- Thulium Laser/ Patriot 1 family of lasers

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Indications for use

Indications for Use Statement:

510(k) Number (if known): K162334

Device Name: Patriot 1 Family of Lasers and Accessories

Indications for Use:

The Patriot 1 Family of Lasers, 400, 600 and 1000 micron sterile, disposable, single use fibers are indicated for incision, excision, resection, ablation, vaporization and coaqulation of soft tissue encountered in urology, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery general surgery and arthroscopy.

Urology

Open and endoscopic surgery (incision, excision, ablation, vaporization, Coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Uretheral 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

Prescription Use: X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

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Gastroenterology

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

Prescription Use: X 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)

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Thoracic and Pulmonary

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

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

Gynecology

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

ENT

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

Prescription Use: _ X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

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Dermatology and Plastic Surgery

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

Prescription Use: X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

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General Surgery

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

Prescription Use: __X _________________AND/OR Over the Counter Use: (Part 21 CFR 801 Subpart D)

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

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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

Note: The Patriot 1 180 and 200 are only cleared for BPH when using over 150 W

Prescription Use: __ X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

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SPECIFICATIONS

Patriot 1 Family of Lasers Technical Specifications

Laser Type:	Tm:Fiber
Wavelength:	1.94 microns
Power to Tissue:	5 to 120, 150, 180, 200 Watts
Operating Modes:	Continuous
Beam Delivery:	400, 600 and 1000 micron fibers. Specialtyfibers also available.
Aiming Beam:	450, Blue Diode, Adjustable
Electrical Supply:	230 VAC, 2.4 kVA, 50/60 Hz
Cooling:	Closed cycle, internal
Dimensions:	H: 35.3L: 29.3W: 19.8
Weight:	TBD Pounds

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General Device Description (unmodified predicate devices vs new modified devices):

The U. S. Laser Worx Family of lasers are surgical instrument for use in general and plastic surgery and in dermatology (GEX).

The Patriot 1 Family of lasers are installed with a single Tm:Fiber Laser Source with CW emission at 1.94 microns with adjustable power from 5 W to the maximum output power (as given below). The laser radiation is delivered to the tissue to be treated through fiber optics.

The Patriot 1 Family (that includes 120, 150, 180 and the 200) and its accessories are intended for use in surqical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coaqulation 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.

Note: the Patriot 1 180 and 200 are only approved for the treatment of BPH when used at power levels greater than 150W.

The Patriot 1 Family has the following models (and related main characteristics):

Patriot 1 120	5 to 120 Watts to tissue
Patriot 1 150	5 to 150 Watts to tissue
Patriot 1 180	5 to 180 Watts to tissue
Patriot 1 200	5 to 200 Watts to tissue

All models of the Patriot 1 Family share the same structure, the same components and the same software. The differentiation of the models derives only from the factory set of the maximum output power of the laser resonator.

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SUBSTANTIAL EQUIVALENCE SUMMARY

Company/Specifications	US. Laser Worx, Inc.Patriot 1 Family ofLasers	AllMed Systems Inc.Revolix 120	Quanta System SPACyber Tm 120, 150,180 and 200
Concurrence:510(k) Number:	Pending	K070476	K131081
Laser Medium:	Tm:Fiber	Tm:Fiber	Tm:Fiber
Wavelength:	1.94 microns	2.01 microns	2.01 microns
Power to Tissue:	5 to 120, 150, 180 and200 Watts	5 to 120 Watts	1 to 120, 150, 180 and200 Watts
OperatingModes:	Continuous	Continuous and Pulsed	Continuous and Pulsed
Pulsed Mode:	CW	50 ms to CW	10 to 1,000 ms, CW
Beam Delivery:	400, 600 and 1000micron fibers. Specialtyfibers also available	200, 400, 600 and 1000micron fibers. Specialtyfibers also available	600, 800 and 1000micron fibers. Specialtyfibers also available
Aiming Beam:	450 nm, Blue Diode,adjustable	635 nm Red Diode, 1mWAdjustable	635 nm Red Diodeadjustable
ElectricalSupply:	230 VAC, 30 Amps,50/60 Hz,	230 VAC, 2.4 kVA,50/60 Hz	200-240, 50/60 Hz, 16Amps
Cooling:	Closed cycle, internal	Closed cycle, internal	Closed cycle, internal
Dimensions:	H: 35.3"W: 19.8"L: 29.3″	H: 38"W: 17"L: 35"	H: 43.3"W: 21.6"L: 29.5"
Weight:	TBD Pounds	330 Pounds	352 Pounds

NOTE: The Patriot 1 180 and 200 are only cleared for BPH when using over 150 Watts

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From a design and clinical perspective, the predicate and candidate laser devices, Summary: are the same technology and have the same intended uses. Based upon the fact that the devices are extremely similar, the Patriot 1 Family of Lasers and Accessories should not raise any concerns regarding its overall safety and/or effectiveness.
Non-Clinical Performance Data:

Performance Standards: THERE ARE NO PERFORMANCE STANDARDS NECESSARY/REQUIRED FOR THIS DEVICE.

IEC safety standards met:

60601-1 ED 3.1(2012)

60601-1-2:2014 4th Ed

60601-2-22 Ed 3.1(2012)

60601-1:2005

60601-1 ED3 (2007) AMENDMENT 1(2013)

60601-1:14(2014) —CANADA

60825-1 2007

ADDITIONALLY, WE PERFORMED NUMEROUS BENCH TESTS INVOVING POWER VERIFICATIONS, MEASUREMENTS, ACCURACY OF SOFTWARE AND ENERGY TRANSMISSION

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.