The MANTA810 diode laser is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Cyneology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

The MANTA980 diode laser is indicated for use in surgical application, incision, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

The MANTA1064 diode laser is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics. Podiatry, Arthroscopy, Spinal Surgery, Gyneology, Pulmonary Surgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

The MANTA1470 diode laser is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

The MANTA1940 diode laser is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gyneology, Pulmonary Surgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

Device Description

The MANTA diode lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode, the laser system can radiate one factory set wavelength with any of the following: 810nm, 980nm, 1064nm, 1470nm or 1940nm.

The MANTA is a compact diode laser with a high-resolution color touchscreen for user control.

AI/ML Overview

The provided document is a 510(k) premarket notification for the MANTA Laser Family. It focuses on establishing substantial equivalence to a predicate device (Quanta Diode Laser Family, K100558) rather than presenting a study to prove acceptance criteria for device performance in the way clinical diagnostic AI/ML products typically do.

Therefore, much of the requested information regarding a study proving acceptance criteria for AI performance (e.g., sample size for test sets, data provenance, expert qualifications, ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable or available in this document.

The document primarily addresses the safety and performance of a laser surgical instrument, which is a hardware device, through adherence to recognized international standards and comparison of technical specifications.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the context of a performance study for AI. Instead, it compares the technical specifications of the MANTA device to a predicate device to demonstrate substantial equivalence. The "performance testing" section refers to adherence to safety and electrical standards.

Specification	Predicate Device (Quanta) Performance (K100558)	Subject Device (MANTA) Reported Performance	Substantial Equivalence
Regulation Number	21 CFR 878.4810	21 CFR 878.4810	Equivalent
Product Code	GEX	GEX	Equivalent
Regulatory Class	Class II	Class II	Equivalent
Laser media	Diode laser	Diode laser	Equivalent
Use of device	RX only	RX only	Equivalent
Max. power (Watts)	30 – 808nm, 30 – 980nm, 30 – 1064nm, 15 – 1470nm, 5 - 1950nm	28 – 810nm, 28 – 980nm, 24 – 1064nm, 12 – 1470nm, 5 – 1940nm	Equivalent
Wavelength (nm)	808, 980, 1064, 1470, 1950	810, 980, 1064, 1470, 1940	Equivalent
Laser class	4	4	Equivalent
Output Mode	CW, pulsed, single pulse	CW, pulsed, single pulse	Equivalent
Pulse Duration	3 msec – 2.5 sec adjustable	10 msec – 30 sec adjustable	Equivalent
Pulse frequency	0.016 - 250 Hz	0.02 – 50 Hz	Equivalent
Aiming Beam	Red 650nm (<5mW)	Red 635-650nm (<5mW)	Equivalent
Cooling	Air	Air	Equivalent
Laser Beam Delivery	Fiber	Fiber	Equivalent
User Interface	Color touch screen	Color touch screen	Equivalent
Power Source	100-240V, 50-60Hz	100 - 240 V, 47-63 Hz	Equivalent
Dimensions & Weight	39 cm (L) x 33 cm (W) x 25 cm (H), 8 Kg.	22 cm (L) x 22 cm (W)x 10 cm (H), 3.5 Kg.	Equivalent
Adherence to Standards	Implied adherence via predicate	IEC 60601-1, IEC 60825-1, EN 60601-1-2, IEC 60601-2-22, IEC 60601-1-6, IEC 62304	Demonstrated

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

Not applicable. This is a hardware device approval, not an AI/ML diagnostic. No specific "test set" of patient data is mentioned for performance evaluation in this context. The "testing" refers to verification and validation of the device's physical and electrical characteristics against engineering standards.

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

Not applicable. No ground truth established by experts is mentioned as this is not an AI/ML diagnostic device requiring such evaluation.

4. Adjudication Method

Not applicable. There is no mention of adjudication for a test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document does not describe an AI/ML product or an MRMC study.

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

Not applicable. This is a laser surgical instrument, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of AI/ML. The "ground truth" for the laser device's performance would be its adherence to established engineering specifications and safety standards, verified through physical testing.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML component described that would require a training set.

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

Not applicable. There is no AI/ML component described.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):

The device (MANTA Laser Family) demonstrates that it meets "acceptance criteria" by showing substantial equivalence to a legally marketed predicate device (Quanta Diode Laser Family, K100558) and by adherence to recognized international consensus standards for medical electrical equipment and laser safety.

Substantial Equivalence Study: The core of the submission is a comparison table (Pages 6-8) that directly compares the MANTA Diode Laser Family's specifications (e.g., maximum power, wavelength, output mode, cooling, user interface) to those of the predicate device. The document states, "The minor differences in design/operation are only a question of usability and do not play a role in safety or effectiveness as the fundamental functions and the indications for use are the same."
Performance Testing against Standards: The document lists several international standards (e.g., IEC 60601 series for electrical safety, IEC 60825-1 for laser safety, IEC 62304 for software life cycle process) that the MANTA systems have been tested against (Page 9). Successful testing against these standards implies the device meets the safety and performance requirements codified within them. The document explicitly states "Performance testing" followed by this list of standards.
Animal or Clinical Studies: The document explicitly states: "Animal or clinical studies: None" (Page 10), further emphasizing that the substantial equivalence and adherence to standards are the primary methods of demonstrating safety and effectiveness for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

November 18, 2022

SQUALUS MED Ltd. Gil Shapira CEO 7 HaEshel Street Caesarea, 3088900 Israel

Re: K222701

Trade/Device Name: MANTA Laser 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: August 31, 2022 Received: September 7, 2022

Dear Gil Shapira:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the text "Jianting Wang -S" in a large, sans-serif font. The text is black and appears to be centered. The background is plain white. The text is likely a name, possibly followed by an initial.

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222701

Device Name MANTA Diode Lasers

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K22701

MANTA Laser Family

Submitter:	SQUALUS MED Ltd.7 HaEshel Street,Caesarea 3088900Israel
Contact person:	Gil Shapira, CEO
Phone:	+972 4 6779919
Fax:	+972 4 8591505
E-Mail:	shapirag@squalusmed.com
Type of 510(k):	Traditional
Date Prepared:	August 28, 2022
Device Trade name	MANTA Diode Laser Family
Common name	Diode Laser System
ClassificationName:	Laser surgical instrument for use in general and plastic surgery and indermatology
Device productcode:	GEX
DeviceClassification	21 CFR 878.4810
PredicateDevices:	Quanta Diode Laser Family (K100558)

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Device Description:

The MANTA is a compact diode laser with a high-resolution color touchscreen for user control.

Indications for Use:

The Indications for use are a subset of the Indications for Use of the predicate device. There is no change in content of the Indications for Use claimed for the MANTA Diode Laser Family, or addition of any new indications.

The MANTA810 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

The MANTA980 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

The MANTA1064 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

The MANTA1470 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures.

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The MANTA1940 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. Substantial Equivalence

Specification	Subject device	Predicate Device	SubstantialEquivalence
510(k)Number	Pending	K100558
Manufacturer	SQUALUS MED Ltd.	Quanta System S.p.a
RegulationNumber	21 CFR 878.4810	21 CFR 878.4810	Equivalent
Product Code	GEX	GEX	Equivalent
RegulatoryClass	Class II	Class II	Equivalent
Indicationsfor Use	The MANTA810 diode laser isindicated for use in surgicalapplications requiring thevaporization, incision, excision,ablation, cutting and hemostasis,or coagulation of soft tissue inconjunction with endoscopicequipment for medical specialistincluding: Urology, ThoracicSurgery, Plastic Surgery andDermatology, General Surgery,Ophthalmology, Orthopedics,Podiatry, Arthroscopy, SpinalSurgery, Gynecology, PulmonarySurgery, Neurosurgery,Gastroenterology,Head/neck/ENT and Radiology,Oral Surgery and Dentalprocedures.The MANTA980 diode laser isindicated for use in surgicalapplications requiring thevaporization, incision, excision,ablation, cutting and hemostasis,or coagulation of soft tissue in	The Quanta System Quanta Diode LaserFamily, including the QUANTA532,QUANTA808, QUANTA940,QUANTA1064, QUANTA1320,QUANTA1470, and QUANTA1950(and all their double wavelengthcombination and theirdelivery accessories used to deliveroptical energy) are indicated for use insurgical applications requiring thevaporization, incision, excision,ablation, cutting and hemostasis, orcoagulation of soft tissue in conjunctionwith endoscopic equipment for medicalspecialist including: Urology (BPH),Genitourinary (Urology), ThoracicSurgery, Plastic Surgery andDermatology, Aesthetics includingvascular lesions and hair removal,General Surgery, Ophthalmology,Orthopedics, Podiatry, Arthroscopy,Spinal Surgery, Gynecology, PulmonarySurgery, Neurosurgery,Gastroenterology, Head/neck/ENT andRadiology, Endovascular coagulation,Oral Surgery and Dental procedures.Page 5-3

Traditional 510(k)-MANTA-510(k) Summary- Section 5

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SQUALUS

7 HaEshel Street, Caesarea 3088900, ISRAEL | Tel: +972 4 6779919 | Fax: +972 4 8591505 shapirag@squalusmed.com | www.squalusmed.com

conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. The MANTA1064 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. The MANTA1470 diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery,

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SQUALUS

7 HaEshel Street, Caesarea 3088900, ISRAEL | Tel: +972 4 6779919 | Fax: +972 4 8591505 shapirag@squalusmed.com | www.squalusmed.com

	Ophthalmology, Orthopedics,Podiatry, Arthroscopy, SpinalSurgery, Gynecology, PulmonarySurgery, Neurosurgery,Gastroenterology,Head/neck/ENT and Radiology,Oral Surgery and Dentalprocedures.The MANTA1940 diode laser isindicated for use in surgicalapplications requiring thevaporization, incision, excision,ablation, cutting and hemostasis,or coagulation of soft tissue inconjunction with endoscopicequipment for medical specialistincluding: Urology, ThoracicSurgery, Plastic Surgery andDermatology, General Surgery,Ophthalmology, Orthopedics,Podiatry, Arthroscopy, SpinalSurgery, Gynecology, PulmonarySurgery, Neurosurgery,Gastroenterology,Head/neck/ENT and Radiology,Oral Surgery and Dentalprocedures.
Laser media	Diode laser	Diode laser	Equivalent
Use of device	RX only	RX only	Equivalent
Max. power(Watts)	28 – 810nm28 – 980nm24 – 1064nm12 – 1470nm5 – 1940nm	30 – 808nm30 – 980nm30 – 1064nm15 – 1470nm5 - 1950	Equivalent(seeconclusion onpage 5-X)
Wavelength(nm)	810, 980, 1064, 1470, 1940	808, 980, 1064, 1470, 1950	Equivalent(seeconclusion onpage 5-7)
Laser class	4	4	Equivalent
Output Mode	CW, pulsed, single pulse	CW, pulsed, single pulse	Equivalent
			Page 5-7

PulseDuration	10 msec – 30 sec adjustable	3 msec – 2.5 sec adjustable	EquivalentSee conclusionon page 5-7)
Pulsefrequency	0.02 – 50 Hz	0.016 - 250 Hz	EquivalentSee conclusionon page 5-7)
Aiming Beam	Red 635-650nm (<5mW)	Red 650nm (<5mW)	Equivalent
Cooling	Air	Air	Equivalent
Laser BeamDelivery	Fiber	Fiber	Equivalent
UserInterface	Color touch screen	Color touch screen	Equivalent
Power Source	100 - 240 V, 47-63 Hz	100-240V, 50-60Hz	Equivalent
Dimensions& Weight	22 cm (L) x 22 cm (W)x 10 cm(H)3.5 Kg.	39 cm (L) x 33 cm (W) x 25 cm (H)8 Kg.	Equivalent

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Performance testing

The MANTA systems have been tested against:

Number of Standard	Name of Standard
IEC 60601-1:2005+COR1:2006, COR2:2007,AMD1:2012	Medical electrical equipment Part 1: General requirements for basicsafety and essential performance
IEC 60825-1:2014 (Third Edition)	Safety of Laser Products – Part 1: Equipment classification andrequirements
EN 60601-1-2:2014 (Fourth Edition)	Medical electrical equipment Part 1-2: General requirements forsafety - Collateral standard: Electromagnetic compatibility –Requirements and tests.
IEC 60601-2-22:2007 (Third Ed.)+A1:2012for use in conjunction with IEC 60601-1:2005 (Third Ed.) + A1:2012	Medical electrical equipment Part 2-22: Particular requirements forbasic safety and essential performance of surgical, cosmetic,therapeutic and diagnostic laser equipment
IEC 60601-1-6:2010/AMD1:2013& IEC 60601-1:2005, AMD1:2012,AMD2:2020	Medical electrical equipment Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability
IEC 62304:2006 + A1:2015	Medical device software - Software life cycle process

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Substantial Equivalence summary and conclusion Substantial equivalence between the subject device and the predicate device has been evaluated. The minor differences in design/operation are only a question of usability and do not play a role in safety or effectiveness as the fundamental functions and the indications for use are the same.

Animal or clinical studies: None

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.