MANTA Laser

K222701 · Squalus Med , Ltd. · GEX · Nov 18, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K222701
• Device Name: MANTA Laser
• Applicant: Squalus Med , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. 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.

Device Story

MANTA Diode Laser Family is a compact, Class 4 laser system; utilizes laser diodes to emit one of five factory-set wavelengths (810nm, 980nm, 1064nm, 1470nm, or 1940nm). Operated by medical specialists in clinical settings; controlled via high-resolution color touchscreen. Laser energy delivered to soft tissue via fiber-optic delivery accessories; used in conjunction with endoscopic equipment for surgical applications including incision, excision, ablation, and hemostasis. System provides CW, pulsed, and single-pulse output modes. Device benefits patients by enabling precise soft tissue surgical interventions across multiple medical specialties. No clinical or animal data provided; safety and effectiveness supported by bench testing and substantial equivalence to predicate.

Clinical Evidence

No clinical or animal studies were performed. Substantial equivalence is based on bench testing, including compliance with IEC 60601-1 (safety), IEC 60825-1 (laser safety), EN 60601-1-2 (EMC), IEC 60601-2-22 (surgical laser requirements), IEC 60601-1-6 (usability), and IEC 62304 (software life cycle).

Technological Characteristics

Diode laser system; wavelengths: 810, 980, 1064, 1470, 1940 nm. Output modes: CW, pulsed, single pulse. Fiber-optic beam delivery. Air cooling. Power source: 100-240V, 47-63 Hz. Aiming beam: 635-650nm (<5mW). Dimensions: 22x22x10 cm; weight: 3.5 kg. User interface: color touchscreen. Software lifecycle: IEC 62304 compliant.

Indications for Use

Indicated for soft tissue surgical procedures (vaporization, incision, excision, ablation, cutting, hemostasis, coagulation) in conjunction with endoscopic equipment. Applicable to medical specialists in Urology, Thoracic, Plastic/Dermatology, General, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal, Gynecology, Pulmonary, Neurosurgery, Gastroenterology, Head/neck/ENT, Radiology, Oral Surgery, and Dental procedures.

Regulatory Classification

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.

Predicate Devices

• Quanta Diode Laser Family (K100558)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

| <div> <span> <b> <span style="font-size: 16px;">☑</span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> <span style="font-size: 16px;">☐</span> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# K22701

# MANTA Laser Family

| Submitter: | SQUALUS MED Ltd.<br>7 HaEshel Street,<br>Caesarea 3088900<br>Israel |
|--------------------------|----------------------------------------------------------------------------------------|
| Contact person: | Gil Shapira, CEO |
| Phone: | [phone] |
| Fax: | [phone] |
| E-Mail: | [e-mail] |
| Type of 510(k): | Traditional |
| Date Prepared: | August 28, 2022 |
| Device Trade name | MANTA Diode Laser Family |
| Common name | Diode Laser System |
| Classification<br>Name: | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology |
| Device product<br>code: | GEX |
| Device<br>Classification | 21 CFR 878.4810 |
| Predicate<br>Devices: | Quanta Diode Laser Family (K100558) |

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#### 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.

### 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 | Substantial<br>Equivalence |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 510(k)<br>Number | Pending | K100558 | |
| Manufacturer | SQUALUS MED Ltd. | Quanta System S.p.a | |
| Regulation<br>Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Equivalent |
| Product Code | GEX | GEX | Equivalent |
| Regulatory<br>Class | Class II | Class II | Equivalent |
| Indications<br>for Use | The MANTA810 diode laser is<br>indicated for use in surgical<br>applications requiring the<br>vaporization, incision, excision,<br>ablation, cutting and hemostasis,<br>or coagulation of soft tissue in<br>conjunction with endoscopic<br>equipment for medical specialist<br>including: Urology, Thoracic<br>Surgery, Plastic Surgery and<br>Dermatology, General Surgery,<br>Ophthalmology, Orthopedics,<br>Podiatry, Arthroscopy, Spinal<br>Surgery, Gynecology, Pulmonary<br>Surgery, Neurosurgery,<br>Gastroenterology,<br>Head/neck/ENT and Radiology,<br>Oral Surgery and Dental<br>procedures.<br>The MANTA980 diode laser is<br>indicated for use in surgical<br>applications requiring the<br>vaporization, incision, excision,<br>ablation, cutting and hemostasis,<br>or coagulation of soft tissue in | The Quanta System Quanta Diode Laser<br>Family, including the QUANTA532,<br>QUANTA808, QUANTA940,<br>QUANTA1064, QUANTA1320,<br>QUANTA1470, and QUANTA1950<br>(and all their double wavelength<br>combination and their<br>delivery accessories used to deliver<br>optical energy) are indicated for use in<br>surgical applications requiring the<br>vaporization, incision, excision,<br>ablation, cutting and hemostasis, or<br>coagulation of soft tissue in conjunction<br>with endoscopic equipment for medical<br>specialist including: Urology (BPH),<br>Genitourinary (Urology), Thoracic<br>Surgery, Plastic Surgery and<br>Dermatology, Aesthetics including<br>vascular lesions and hair removal,<br>General Surgery, Ophthalmology,<br>Orthopedics, Podiatry, Arthroscopy,<br>Spinal Surgery, Gynecology, Pulmonary<br>Surgery, Neurosurgery,<br>Gastroenterology, Head/neck/ENT and<br>Radiology, Endovascular coagulation,<br>Oral Surgery and Dental procedures.<br>Page 5-3 | |

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

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# SQUALUS

7 HaEshel Street, Caesarea 3088900, ISRAEL | Tel: [phone] | Fax: [phone] [e-mail] | 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: [phone] | Fax: [phone] [e-mail] | www.squalusmed.com

| | Ophthalmology, Orthopedics,<br>Podiatry, Arthroscopy, Spinal<br>Surgery, Gynecology, Pulmonary<br>Surgery, Neurosurgery,<br>Gastroenterology,<br>Head/neck/ENT and Radiology,<br>Oral Surgery and Dental<br>procedures.<br>The MANTA1940 diode laser is<br>indicated for use in surgical<br>applications requiring the<br>vaporization, incision, excision,<br>ablation, cutting and hemostasis,<br>or coagulation of soft tissue in<br>conjunction with endoscopic<br>equipment for medical specialist<br>including: Urology, Thoracic<br>Surgery, Plastic Surgery and<br>Dermatology, General Surgery,<br>Ophthalmology, Orthopedics,<br>Podiatry, Arthroscopy, Spinal<br>Surgery, Gynecology, Pulmonary<br>Surgery, Neurosurgery,<br>Gastroenterology,<br>Head/neck/ENT and Radiology,<br>Oral Surgery and Dental<br>procedures. | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------|
| Laser media | Diode laser | Diode laser | Equivalent |
| Use of device | RX only | RX only | Equivalent |
| Max. power<br>(Watts) | 28 – 810nm<br>28 – 980nm<br>24 – 1064nm<br>12 – 1470nm<br>5 – 1940nm | 30 – 808nm<br>30 – 980nm<br>30 – 1064nm<br>15 – 1470nm<br>5 - 1950 | Equivalent<br>(see<br>conclusion on<br>page 5-X) |
| Wavelength<br>(nm) | 810, 980, 1064, 1470, 1940 | 808, 980, 1064, 1470, 1950 | Equivalent<br>(see<br>conclusion on<br>page 5-7) |
| Laser class | 4 | 4 | Equivalent |
| Output Mode | CW, pulsed, single pulse | CW, pulsed, single pulse | Equivalent |
| | | | Page 5-7 |
| | | | |
| Pulse<br>Duration | 10 msec – 30 sec adjustable | 3 msec – 2.5 sec adjustable | Equivalent<br>See conclusion<br>on page 5-7) |
| Pulse<br>frequency | 0.02 – 50 Hz | 0.016 - 250 Hz | Equivalent<br>See conclusion<br>on page 5-7) |
| Aiming Beam | Red 635-650nm (<5mW) | Red 650nm (<5mW) | Equivalent |
| Cooling | Air | Air | Equivalent |
| Laser Beam<br>Delivery | Fiber | Fiber | Equivalent |
| User<br>Interface | Color touch screen | Color touch screen | Equivalent |
| Power Source | 100 - 240 V, 47-63 Hz | 100-240V, 50-60Hz | Equivalent |
| Dimensions<br>& Weight | 22 cm (L) x 22 cm (W)x 10 cm<br>(H)<br>3.5 Kg. | 39 cm (L) x 33 cm (W) x 25 cm (H)<br>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+<br>COR1:2006, COR2:2007,<br>AMD1:2012 | Medical electrical equipment Part 1: General requirements for basic<br>safety and essential performance |
| IEC 60825-1:2014 (Third Edition) | Safety of Laser Products – Part 1: Equipment classification and<br>requirements |
| EN 60601-1-2:2014 (Fourth Edition) | Medical electrical equipment Part 1-2: General requirements for<br>safety - Collateral standard: Electromagnetic compatibility –<br>Requirements and tests. |
| IEC 60601-2-22:2007 (Third Ed.)<br>+A1:2012<br>for use in conjunction with IEC 60601-<br>1:2005 (Third Ed.) + A1:2012 | Medical electrical equipment Part 2-22: Particular requirements for<br>basic safety and essential performance of surgical, cosmetic,<br>therapeutic and diagnostic laser equipment |
| IEC 60601-1-6:2010/<br>AMD1:2013<br>& IEC 60601-1:2005, AMD1:2012,<br>AMD2:2020 | Medical electrical equipment Part 1-6: General requirements for<br>basic safety and essential performance - Collateral standard:<br>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