The Cyber Tm Family (that Includes Cyber Tm 150, Cyber Tm 180 and Cyber Tm 200) and its accessories are intended for use in surgical procedures using open, laparoscopic incision, resection, abletton, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urclogy, Gastroentarology, Thoracio Gynecslogy, ENT, Demainly, Plastic Surgery, General Surgary and Arthroscopy.

Note; The Cyber Tm 180 and Cyber Tm 200 are only approved for the treatment of BPH when used at power levels greater than 150V.

Device Description

The Cyber Tm Family is laser surgical instrument for use in general and plastic surgery and in dermatology (GEX). In the Cyber Tm Family is installed a single Tm:YAG Laser Source with CW emission at 2.01um 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 Cyber Tm Family (that includes Cyber Tm 150, Cyber Tm 150, Cyber Tm 180 and Cyber Tm 200) and its accessories are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, 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.

AI/ML Overview

The acceptance criteria and study proving device performance are described below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Basic Safety and Effectiveness	The Cyber Tm Family devices (including Cyber Tm 120, Cyber Tm 150, Cyber Tm 180, and Cyber Tm 200) and their accessories must comply with all applicable safety and performance standards for medical electrical equipment and laser products. This includes:	The Cyber Tm Family (including Cyber Tm 120, Cyber Tm 150, Cyber Tm 180, and Cyber Tm 200) and its accessories were tested and found to comply with: • IEC 60601-1:2005 • IEC 60601-1-2:2005 • IEC 60601-1-4: 1996 (First Ed.) -+ Am.l: 1999 (Consolidated 1.1 Ed.) - for use with IEO 60601-1 (1988), Amts 1 (1991) and 2 (1995) • IEC 60601-2-22:2005 • IEC 60825-1:2007 They also comply with European Medical Device 93/42/EEC.
Substantial Equivalence - Tissue Effects (for modified devices vs. predicate)	The modified devices (Cyber Tm 180 and Cyber Tm 200) must demonstrate comparable tissue effects (depth of thermal injury, coagulation, ablation depth, carbonization) to the predicate devices (Cyber Tm 120 and Cyber Tm 150) under equivalent operating conditions (when accounting for power density through fiber diameter).	A specific bench testing was conducted on the Cyber Tm Family devices. The depth of thermal injury and coagulation were measured and compared to the unmodified predicate devices and "did not show significant differences." The ablation depth was also measured and "found to be of comparable depth, keeping the same power density through the use of different fiber diameter." Other tissue effects such as carbonization were also "found to be comparable." This suggests the modified devices meet the criteria for comparable tissue effects to the predicate devices.
Intended Use Equivalence	The modified devices (Cyber Tm 180 and Cyber Tm 200) must have the same intended use as the predicate devices (Cyber Tm 120 and Cyber Tm 150). (Note: Specific power levels for BPH treatment are a conditional part of the intended use for the higher power models).	The "intended use of the predicate devices (Legally Marketed Devices) are the same as the modified devices." This indicates the modified devices fulfill the intended use equivalence. The document explicitly states for the Cyber Tm 180 and Cyber Tm 200 that they "are only approved for the treatment of BPH when used at power levels greater than 150W," which is a specific condition within the broader stated intended use.
Technological Characteristics Equivalence	The modified devices (Cyber Tm 180 and Cyber Tm 200) must share the same structure, components, software, and technological characteristics as the unmodified predicate devices, with the primary differentiation being the factory-set maximum output power.	"All models of the Cyber Tm 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." This demonstrates that the technological characteristics, apart from the maximum output power, are equivalent.

Study Proving Device Meets Acceptance Criteria:

The device's acceptance criteria are met through performance and basic safety testing, and a specific bench testing that supports the determination of substantial equivalence to the predicate devices.

Study Type: This appears to be a bench testing/laboratory study combined with compliance assessments to established international safety and performance standards. It is not a clinical study involving human or animal subjects, nor is it a multi-reader multi-case (MRMC) study.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated as a number of "samples" in a traditional sense. The bench testing involved measuring tissue effects on the proposed Cyber Tm Family devices (Cyber Tm 180 and Cyber Tm 200) and comparing them to unmodified predicate devices (Cyber Tm 120 and Cyber Tm 150). The number of actual tissue samples or laser firing instances used for these measurements is not specified.
Data Provenance: The testing was conducted by Quanta System SpA, the manufacturer, based in Italy. The data is retrospective in the sense that it's a submission of bench test results, not a prospective clinical trial.

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

Not applicable. This study does not involve human expert interpretation or labeling of data for ground truth establishment. The "ground truth" for the bench testing would be the physical measurements of tissue effects, conducted by technical personnel/engineers, and direct comparison to the predicate device's performance.

4. Adjudication Method for the Test Set:

Not applicable. As there are no human readers or interpretations of complex data requiring consensus, no adjudication method was used. The comparison was based on direct measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC comparative effectiveness study was not done. This submission focuses on engineering and performance changes of a laser surgical instrument, primarily demonstrating safety and substantial equivalence through bench testing, not diagnostic effectiveness with human readers.

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

Partially Applicable (in a different context): While not an "algorithm" in the typical AI sense, the performance evaluation in this submission focuses on the standalone performance of the laser device itself (i.e., its ability to produce specific tissue effects) without human intervention in the measurement of those effects. There is no AI algorithm being evaluated here.

7. The Type of Ground Truth Used:

The ground truth used for the bench testing was direct physical measurement of tissue effects (e.g., depth of thermal injury, coagulation, ablation depth, carbonization). This is a form of objective, quantitative data derived from the interaction of the device with tissue.

8. The Sample Size for the Training Set:

Not applicable. This submission does not describe an AI/machine learning model, and therefore, there is no "training set." The predicate devices represent established performance benchmarks rather than a training set for an algorithm.

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

Not applicable. As there is no training set for an AI model, this question is not relevant to this submission.

Summary

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K131081

JUL 0 3 2013

7. 510(K) SUMMARY - Device Modification

Introduction:

This document contains the 510(k) Summary for the Cyber Tm Family. The content of this summary is based on the requirements of 21 CFR 807.92(c). This is the first submission for the Cyber Tm Family

Applicant /	Quanta System SPA
Manufacturer	Via IV Novembre, 116
Name and Address:	Solbiate Olona (VA)
	Italy, 21058

510(k) Contact Person:

Maurizio Bianchi Regulatory Affairs Manager Quanta System SPA

Email: maurizio.bianchi@guantasystem.com Phone: +39 0331 376797 +39 0331 367815 Fax:

Date Prepared: Device Name:

November 20th, 2012 Cyber Tm Family

21 CFR 878.4810

Cyber

Classification: Class II

Classification Name:

Laser surgical instrument for use in general and plastic surgery and in dermatology.

Regulation Number:

Product Code: GEX

Basis for Submission: Technology, Engineering, and Performance Changes

Legally Marketed Device

The Cyber Tm Family is claimed to be substantially equivalent to these legally marketed devices:

Cyber Tm 120 of the Cyber Surgical Laser Family (K090962) Quanta System SpA
Cyber Tm 150 (K102749) Quanta System SpA
RevoLix Family (K110941) - AllMed System Inc.

Performance Standards:

There are no mandatory performance standards for this device.

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

The Cyber Tm Family is laser surgical instrument for use in general and plastic surgery and in dermatology (GEX).

In the Cyber Tm Family is installed a single Tm:YAG Laser Source with CW emission at 2.01um 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 Cyber Tm Family (that includes Cyber Tm 150, Cyber Tm 150, Cyber Tm 180 and Cyber Tm 200) and its accessories are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, 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.

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

Models	Type of laser	Wavelength	Min Power	Max Power
Cyber Tm 120 (unmodified) predicate device	CW Tulium: YAG	2.010 μm	5 W	120 W
Cyber Tm 150 (unmodified) predicate device	CW Tulium: YAG	2.010 μm	5 W	150W
Cyber Tm 180 (new) modified device	CW Tulium:YAG	2.010 μm	5 W	180 W
Cyber Tm 200 (new) modified device	CW Tulium: YAG	2.010 μm	5 W	200 W

The Cyber Tm Family has the following models (and related main characteristics):

The first two models of the Cyber Tm Family, the Cyber Tm 120 and Cyber Tm 150. have been already cleared and represent the unmodified devices (Legally Marketed Devices). The other two, the Cyber Tm 180 and Cyber Tm 200, are the derived from the previous ones.

All models share the same structure, the same components and the same software. The differentation of the models derives only from the factory set of the maximum output power, as detailed in the next section.

Description of the modification:

The first two models of the Cyber Tm Family, the Cyber Tm 120 and Cyber Tm 150, have been already cleared and represent the unmodified devices (Legally Marketed Devices). The other two, the Cyber Tm 180 and Cyber Tm 200, are the derived from the previous ones.

The modification of the devices is limited to the Tm:YAG Laser Source that is installed inside Cyber Tm Family.

So all models of the Cyber Tm Family share the same structure, the same components and the same software. The differentation of the models derives only from the factory set of the maximum output power of the laser resonator.

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Summary of Performance and basic Safety testing:

The Cyber Tm Family (that includes Cyber Tm 120, Cyber Tm 150, Cyber Tm 180 and Cyber Tm 200) and its accessories have been tested in accordance with:

IEC 60601-1:2005
ﺎ
IEC 60601-1-2:2005 ı
IEC 60601-1-4: 1996 (First Ed.) -+ Am.l: 1999 (Consolidated 1.1 Ed.) -
for use with IEO 60601-1 (1988), Amts 1 (1991) and 2 (1995) -
। IEC 60601-2-22:2005
، IEC 60825-1:2007

The Cyber Tm Family (that includes Cyber Tm 120, Cyber Tm 150, Cyber Tm 180 and Cyber Tm 200) and its accessories comply with European Medical Device 93/42/EEC.

Moreover a specific bench testing was conducted on the proposed Cyber Tm Family devices to support a determination of substantial equivalence to the predicate device. The depth of thermal injury and coaqulation were measured and compared to the unmodified predicate devices and did not show significant differences. The ablation depth was also measured and found to be of comparable depth, keeping the same power density through the use of different fiber diameter. Other tissue effects such as carbonization were also found to be comparable.

Indications for Use

The Cyber Tm Family is laser surgical instrument for use in general and plastic surgery and in dermatology (GEX).

In the Cyber Tm Family is installed a single Tm:YAG Laser Source with CW emission at 2010 nm with adjustable power from 5 W to the maximum output power (as qiven below). The laser radiation is delivered to the tissue to be treated through fiber optics.

Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.

Note: The Cyber Tm 180 and Cyber Tm 200 are only approved for the treatment of BPH when used at power levels greater than 150W

The Cyber Tm Family has the following models:

Models	Type of laser	Wavelength	Min Power	Max Power
Cyber Tm 120 (unmodified) predicate device	CW Tulium:YAG	2.010 $ \mu $ m	5 W	120 W
Cyber Tm 150 (unmodified) predicate device	CW Tulium:YAG	2.010 $ \mu $ m	5 W	150W
Cyber Tm 180 (new) modified device	CW Tulium:YAG	2.010 $ \mu $ m	5 W	180 W
Cyber Tm 200 (new) modified device	CW Tulium:YAG	2.010 $ \mu $ m	5 W	200 W

The first two models of the Cyber Tm Family, the Cyber Tm 120 and Cyber Tm 150, have been

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already cleared and represent the unmodified predicate devices (Legally Marketed Devices). The Cyber Tm 180 and Cyber Tm 200, are the derived from the previous ones. The RevoLix Family (K110941) has been already cleared and is a secondary predicate device (Legally Marketed Devices).

The intended use of the predicate devices (Legally Marketed Devices) are the same as the modified devices.

Substantial Equivalence:

The first two models of the Cyber Tm Family, the Cyber Tm 120 and Cyber Tm 150, have been already cleared and represent the unmodified predicate devices (Legally Marketed Devices). The Cyber Tm 180 and Cyber Tm 200. are the derived from the previous ones.

The RevoLix Family (K110941) has been already cleared and is a secondary predicate device (Legally Marketed Devices).

All models of the Cyber Tm Family share the same structure, the same components and the same software. The modified devices have the same intended use and the same technological characteristics and principles of operation as the unmodified devices. It has been demonstrated that the modified devices of the Cyber Tm Family are safe and effective as the unmodified devices and the predicate devices.

Thus the modified devices included in the Quanta System Cyber Tm Family are substantially equivalent to the previously legally marketed devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 that resembles a bird or a human figure in motion, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 3, 2013

Quanta System Spa % Mr. Maurizio Bianchi Via IV Novembre Nº 116 21058 Solbiate Olona (VA) Italy

Re: K131081

Trade/Device Name: Cyber Tm Family Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general surgery and

plastic surgery and in dermatology

Regulatory Class: Class II Product Code: GEX Dated: June 12, 2013 Received: June 13, 2013

Dear Mr. Bianchi:

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

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Page 2 - Mr. Maurizio Bianchi

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 of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm 1 1 5809.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,

Mark N. Melkerson -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 (if known): K131081

Device Name: Cyber Tm Family

Indications for Use:

Urology:

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

	Urethral Strictures

Bladder Neck Incisions (8NI)

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

Ablation of Benign Prostatic Hypertrophy (BHP),
Transurethral incision of the prostate (TUIP)
Laser Resection of the Prostrate
Laser Enucleation of the Prostate
Laser Ablation of the Prostate
Condylomas
Lesions of external genitalia

Note; The Cyber Tm 180 and Cyber Tm 200 are only approved for the treatment of BPH when used at power levels greater than 150V.

Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) C-ncurrence of CDRH, Office of Device Evaluation (ODE) Neil R Ogden … 2013.06.27 115:35:22 -04'00'

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Division of Surgical Devices

510(k) Number K131081

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510(k) Number (if known): K131081

Device Name: Cyber Tm Family Indications for Use: continued

Open and endoscopic gastroenterslogy surgery (incision, essecion, ablation, vaporization, coagulation, 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

Gastric Erosions
Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number K131081

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510(k) Number (if known): K131081

Device Name: Cyber Tm Family

Indications for Use: continued

Gynecology:

Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagnation and homostasis):

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

ENT:

Endoscopic endonasal surgery (incision, resection, shiption, vaporization, coagulation and hemostasis of soft tissus) including: Endonasal/sinus Surgery

Partial turbinectomy
Polypectomy
Dacryocystor hinostomy
Frontal Sinusotomy
Ethmoidectorny
Maxillary antrostomy
Functional endoscopic sinus surgery
Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal
Tonsillectomy
Adenoidoctomy

Dermatology and Plastic Surgery:

Incision, excision, resection, abletton, vegatiation and hemostasisof soft, mucosal, fatty and cartlaginous thaus, In therapeutic plastic, dermatologic and aesthetic surgical procedures including:

Basal Cell Carcinomas
- Lesion of skin and subcutaneous tissue
- Skin tags
- Plantar warls

Prescription Use (Part 21 C.F.R. 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number K131081

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510(k) Number (if known): K131081

Device Name: Cyber Tm Family

Indications for Use: continued

Gonoral Surgery

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

Cholecystectorny
Lysis of adhesion
Appendactorny Blopsy
Skin incision
Tissue dissection
Excision of external turnors and lesions
Complete or partial resection of internal organs, tumors and lesions
Mastectorny
Hepatectomy
Pancreatectomy Splenectomy
Thyroidectomy
Parathyroidectomy
Herniorrhaphy
Tonsillectorny
Lymphadenectomy
Partial Nephrectorny
Pilonidal Cystectorny
Resection of lipoma
Debridement of Decubitus Ulcer Hemorrhoids
- Debridement of Statis Ulcer

Prescription Use (Part 21 C.F.R. 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) for MXM

Division of Surgical Devices

510{k} Number K131081

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510(k) Number (if known): K131081

Device Name: Cyber Tm Family

Indications for Use: continued

Thoracic and Pulmonary

Open and endbecopic thoracic and pulmon, excision, excision, resection, ablation, vaportzation, coagulation and hemostasis) of soft tissue

Laryngeal lesions
- Airway obstructions including carcinoma
Polyps and granuloma
Palliation of obstructing carcinoma of the tracheobroncial tree

Arthroscopy

Arthroscopy/Orthopedic surgery (excision, ablation and cosgulation of soft and cartileginous (issue);

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

Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number K131081

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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.