K Number
K222701
Device Name
MANTA Laser
Manufacturer
Date Cleared
2022-11-18

(72 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

No
The summary describes a diode laser system for surgical applications and does not mention any AI or ML capabilities.

Yes.
The device is used in surgical applications for vaporization, incision, ablation, cutting, hemostasis, or coagulation of soft tissue, which are actions intended to treat or alleviate a medical condition.

No

The device is indicated for surgical applications such as vaporization, incision, ablation, cutting, hemostasis, and coagulation of soft tissue, which are therapeutic and not diagnostic functions.

No

The device description clearly states it is a "diode laser" with a "laser diode as the beam source" and a "high-resolution color touchscreen for user control," indicating it is a hardware device that utilizes software for control, not a software-only device.

Based on the provided information, the MANTA diode laser is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use clearly states that the device is for surgical applications requiring the vaporization, incision, ablation, cutting, hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment. This describes a device used directly on or within the body for therapeutic or surgical purposes.
  • Device Description: The description details a laser system used as a beam source for surgical procedures.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are used to perform tests on samples taken from the body, not to directly treat or alter tissue within the body. The MANTA diode laser falls under the category of a surgical laser, which is a therapeutic device.

N/A

Intended Use / Indications for Use

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.

Product codes

GEX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The MANTA systems have been tested against:
IEC 60601-1:2005+ COR1:2006, COR2:2007, AMD1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60825-1:2014 (Third Edition) Safety of Laser Products – Part 1: Equipment classification and requirements
EN 60601-1-2:2014 (Fourth Edition) Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility – Requirements and tests.
IEC 60601-2-22:2007 (Third Ed.) +A1:2012 for use in conjunction with IEC 60601- 1:2005 (Third Ed.) + A1:2012 Medical electrical equipment Part 2-22: Particular requirements for basic 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 for basic safety and essential performance - Collateral standard: Usability
IEC 62304:2006 + A1:2015 Medical device software - Software life cycle process

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K100558

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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

1

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

2

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)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

Image /page/4/Picture/0 description: The image shows the word "SQUALUS" in black font with a purple graphic to the left. The graphic is two purple shapes that are next to each other. There is a grey line underneath the word "SQUALUS".

K22701

MANTA Laser Family

| Submitter: | SQUALUS MED Ltd.
7 HaEshel Street,
Caesarea 3088900
Israel |
|--------------------------|----------------------------------------------------------------------------------------|
| 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 |
| Classification
Name: | Laser surgical instrument for use in general and plastic surgery and in
dermatology |
| Device product
code: | GEX |
| Device
Classification | 21 CFR 878.4810 |
| Predicate
Devices: | Quanta Diode Laser Family (K100558) |

5

Image /page/5/Picture/0 description: The image shows the word "SQUALUS" in black letters. To the left of the word is a purple graphic that looks like two rounded rectangles connected together. There is a thin black line underneath the word "SQUALUS".

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.

6

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
Equivalence |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 510(k)
Number | Pending | K100558 | |
| Manufacturer | SQUALUS MED Ltd. | Quanta System S.p.a | |
| Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Equivalent |
| Product Code | GEX | GEX | Equivalent |
| Regulatory
Class | Class II | Class II | Equivalent |
| Indications
for 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 | The Quanta System Quanta Diode Laser
Family, including the QUANTA532,
QUANTA808, QUANTA940,
QUANTA1064, QUANTA1320,
QUANTA1470, and QUANTA1950
(and all their double wavelength
combination and their
delivery accessories used to deliver
optical energy) are 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 (BPH),
Genitourinary (Urology), Thoracic
Surgery, Plastic Surgery and
Dermatology, Aesthetics including
vascular lesions and hair removal,
General Surgery, Ophthalmology,
Orthopedics, Podiatry, Arthroscopy,
Spinal Surgery, Gynecology, Pulmonary
Surgery, Neurosurgery,
Gastroenterology, Head/neck/ENT and
Radiology, Endovascular coagulation,
Oral Surgery and Dental procedures.
Page 5-3 | |

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

7

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,

8

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, 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. | | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------|
| Laser media | Diode laser | Diode laser | Equivalent |
| Use of device | RX only | RX only | Equivalent |
| Max. power
(Watts) | 28 – 810nm
28 – 980nm
24 – 1064nm
12 – 1470nm
5 – 1940nm | 30 – 808nm
30 – 980nm
30 – 1064nm
15 – 1470nm
5 - 1950 | Equivalent
(see
conclusion on
page 5-X) |
| Wavelength
(nm) | 810, 980, 1064, 1470, 1940 | 808, 980, 1064, 1470, 1950 | Equivalent
(see
conclusion on
page 5-7) |
| Laser class | 4 | 4 | Equivalent |
| Output Mode | CW, pulsed, single pulse | CW, pulsed, single pulse | Equivalent |
| | | | Page 5-7 |
| | | | |
| Pulse
Duration | 10 msec – 30 sec adjustable | 3 msec – 2.5 sec adjustable | Equivalent
See conclusion
on page 5-7) |
| Pulse
frequency | 0.02 – 50 Hz | 0.016 - 250 Hz | Equivalent
See conclusion
on page 5-7) |
| Aiming Beam | Red 635-650nm (