ECHOLASER X4

K181510 · El.En Electronic Engineering Spa · GEX · Sep 4, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K181510
• Device Name: ECHOLASER X4
• Applicant: El.En Electronic Engineering Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ECHOLASER X4 laser system is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).

Device Story

Echolaser X4 is a diode laser system emitting at 1064nm in continuous wave mode; designed for soft tissue surgery. System utilizes 1 to 4 optical fibers, allowing independent activation and power adjustment for each fiber. Operated by a physician via footswitch in clinical or surgical settings. Device delivers laser energy to target tissue for cutting, vaporization, ablation, or coagulation; used in conjunction with endoscopic equipment or open surgery handpieces. Provides precise thermal tissue interaction; benefits include controlled surgical outcomes in general, plastic, and dermatological procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on non-clinical bench testing, including conformance to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.

Technological Characteristics

Diode laser source; 1064nm wavelength; continuous wave output mode; 1-4 independent optical fiber channels; 28W max power; 0.3mm beam diameter; 630-670nm aiming beam. Conforms to AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.

Indications for Use

Indicated for soft tissue cutting, vaporization, ablation, and coagulation in endoscopic and open surgical procedures, and for the treatment/removal of vascular lesions (tumors).

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

• DORNIER MEDILAS D 1064 laser system (K080959)

Submission Summary (Full Text)

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September 4, 2018

El.En Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, 50041 It

Re: K181510

Trade/Device Name: Echolaser X4 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: June 5, 2018 Received: June 8, 2018

Dear Paolo Peruzzi:

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/cfpmr/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 entiled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Jennifer R. Stevenson -

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

Enclosure

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## Indications for Use

510(k) Number (if known)

K181510

Device Name ECHOLASER X4

#### Indications for Use (Describe)

The ECHOLASER X4 laser system is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopies), in incision/excision, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| <span> <span style="text-decoration: underline;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(K) Summary ECHOLASER X4

## Submitter:

El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy

## Contact:

Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: [phone] E-mail: [e-mail]

#### Date Summary Prepared:

June 5, 2018

Device Trade Name:

ECHOLASER X4

## Common Name:

Medical Laser system

#### Classification Name:

Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology (GEX)

#### Classification Number:

21 CFR 878.4810

## Equivalent Devices:

DORNIER MEDILAS D 1064 laser system (K080959).

#### Device Description:

The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via 1 to 4 optical fibres. The operator can use 1 to 4 fibres simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.

#### Intended Use:

The ECHOLASER X4 laser system is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes , hysteroscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).

#### Substantial equivalence discussion:

The ECHOLASER X4 is substantially equivalent to the DORNIER MEDILAS D 1064 laser system (K080959).

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| Device Trade Name | Proposed 510(k) Device | Predicate Device |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ECHOLASER | K080959<br>DORNIER MEDILAS D 1064 |
| Indications for Use | The ECHOLASER X4 laser system is intended<br>for use in cutting, vaporization, ablation and<br>coagulation of soft tissue in conjunction with<br>endoscopic equipment (including laparoscopes<br>, hysteroscopes, bronchoscopes, gastroscopes,<br>cystoscopes and colonoscopies), in<br>incision/excision, vaporization, ablation and<br>coagulation of soft tissue in contact and non-<br>contact open surgery (with or without a<br>handpiece), and in the treatment and/or<br>removal of vascular lesions (tumors). | The DORNIER MEDILAS D 1064 Laser<br>Model is intended for use in cutting,<br>vaporization, ablation and coagulation of soft<br>tissue in conjunction with endoscopic<br>equipment (including laparoscopes<br>, hysteroscopes, bronchoscopes, gastroscopes,<br>cystoscopes and colonoscopies), in<br>incision/excision, vaporization, ablation and<br>coagulation of soft tissue in contact and non-<br>contact open surgery (with or without a<br>handpiece), and in the treatment and/or<br>removal of vascular lesions (tumors). |
| Laser Type | DIODE | DIODE |
| Wavelength (μm) | 1064 nm ± 10% | 1064 nm ± 10% |
| Output mode | Multimode | Multimode |
| Maximum delivered Power | 28W | 30W |
| Stability of the output power<br>level | ±20% | ±20% |
| Beam diameter | 0.3 mm | 0.3 mm |
| Mode of operation | Continuous wave | Continuous wave |
| Aiming Beam<br>Laser Type<br>Wavelength<br>Maximum<br>Delivered Output<br>Power | Diode<br>630-670 nm<br>< 3 mW | Diode<br>632 nm<br><1 mW |

The ECHOLASER X4 has the same indications for use as the abovementioned predicate device, with same principle of operation and essentially the same performances.

## Clinical Performance Data:

None

## Non-Clinical Performance Data:

The ECHOLASER X4 was tested for standards conformance with the following standards:

AAMI/ANSI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - Requirements and tests.

IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.

IEC 60825-1- Safety of laser products – Part 1: Equipment classification and requirements.

#### Conclusion:

We can conclude that the ECHOLASER X4 laser system is substantially equivalent to the predicate device .

## Additional Information:

None