ECHOLASER X4

K213594 · Elesta S.P.A · GEX · May 3, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K213594
• Device Name: ECHOLASER X4
• Applicant: Elesta S.P.A
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ECHOLASER X4 laser system is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064 nm.

Device Story

Echolaser X4 is a diode laser system emitting 1064nm light in continuous wave mode; used for interstitial soft tissue necrosis or coagulation. System transmits laser energy via optical fibers; supports 1-4 simultaneous fibers with independent power adjustment. Operated by physician via footswitch; used in clinical settings across multiple surgical specialties. Device provides thermal destruction of target tissue; benefits include minimally invasive tissue treatment. No changes to hardware or performance from predicate K181510; modification limited to updated indications for use language.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical technological characteristics and performance to the primary predicate device.

Technological Characteristics

Diode laser source; 1064nm wavelength (±10%); 28W max power (7W/fiber); continuous wave mode; TEC cooling; SMA 905 output port; Class 4 laser; Class 2 FDA safety classification. Includes emergency switch, remote interlock, and internal power monitoring. Software-controlled emission via footswitch.

Indications for Use

Indicated for patients requiring soft tissue necrosis or coagulation via interstitial irradiation across various surgical specialties including cardiovascular thoracic (excluding heart/pericardial sac), dermatology, ENT, gastroenterology, general, gynecology, head and neck, orthopedics, pulmonology, radiology, and urology.

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

• ECHOLASER X4 (K181510)

Reference Devices

• Visualase Thermal Therapy System (K181859)

Submission Summary (Full Text)

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May 3, 2022

Elesta Spa % Maurizio Pantaleoni RA/QA Consultant Maurizio Pantaleoni Via Borgo Santa Cristina 12 Imola, Bologna 40026 Italy

Re: K213594

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: April 4, 2022 Received: April 6, 2022

Dear Maurizio Pantaleoni:

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.

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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 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-reporting-

combination-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 mediation-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.

Purva Pandya, D.Eng. 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) K213594

Device Name ECHOLASER X4

#### Indications for Use (Describe)

The ECHOLASER X4 laser system is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064 nm.

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

| ☑ Remediation Use (Part 21 CFR 601.21 and P) | ☐ Same-Time Studies (21 CFR 601.21 and s) |
|----------------------------------------------|-------------------------------------------|
|----------------------------------------------|-------------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

# 1. General Information

Applicant:

ELESTA SpA Via Baldanzese, 17 Calenzano (FI) Italy 50041, Italy Tel. [phone] Fax [phone]

Establishment Registration Number: 3015077548

| Contact for the application: | Maurizio Pantaleoni |
|------------------------------|--------------------------------------|
| | Via Borgo Santa Cristina 12 |
| | Imola (BO) 40026, Italy |
| | Tel. [phone] |
| | Email: [e-mail] |

Summary Preparation Date: October 22, 2021

#### Name & Classification 2.

Common Name/Trade Name/Device Name: ECHOLASER X4

Classification names Powered laser surgical instrument (GEX)

Laser surgical instrument for use in general and plastic surgery and Regulation Name in dermatology (21 CFR§878.4810).

Product Code GEX

CLASS: II

### 3. Predicate Devices

| Predicate | Applicant | Device name | 510(k) Number |
|-----------|--------------------------------------|----------------------------------|---------------|
| Primary | EL.EN. ELECTRONIC<br>ENGINEERING SPA | ECHOLASER X4 | K181510 |
| Reference | Medtronic Navigation Inc. | Visualase Thermal Therapy System | K181859 |

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The device modification is related to the ECHOLASER X4, already cleared by the Agency with K181510.

Requested change is related to a language revision of the Intended use of ECHOLASER X4, in order to reflect the description of applications of a predicate device which was unavailable at the of the previous submission K181510. A reference predicate (K181859) is provided in support of the change in the intended use language.

No other changes have been made to the existing ECHOLASER X4 cleared by the Agency under K181510.

The technical features, the design, the performance and safety of the ECHOLASER X4 device are not affected by this device modification since they are precisely the same .

# 4. 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 optical fibers . The operator can use 1 to 4 (or 1 to 2 in case of two channels model) fibers simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.

# 5. Indications for Use

The ECHOLASER X4 laser system is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064nm.

Explanation of Differences: The above indications for use language is different than the indications for use language present in the primary predicate K181510. However, the intended use of the subject and predicate devices is identical (i.e., thermal destruction of the soft tissue of interest). Moreover, the modified language is comparable to the language present in the indications for use of the reference predicate and does not raise different questions of safety and effectiveness.

# 6. Summary of Technological Similarities/Differences

The device modification is related to the language revision of the Intended use of ECHOLASER X4. No other relevant changes have been made to the existing ECHOLASER X4 cleared by the Agency under K181510.

| | Subject Device | Primary Predicate Device | Comments |
|------------------------------------|-------------------------------------------------------------|----------------------------------------------------------|-------------------------------|
| Product Name | ECHOLASER X4 | ECHOLASER X4 | NA |
| 510(K) No. | K213594 | K181510 | NA |
| Applicant | Elesta SpA | El.En. SpA | NA |
| Classification | 21 CFR§878.4810, Laser<br>Surgical Instrument for | 21 CFR§878.4810, Laser<br>Surgical Instrument for Use in | Identical |
| | Subject Device | Primary Predicate Device | Comments |
| | Use in General and Plastic<br>Surgery and in<br>Dermatology | General and Plastic Surgery<br>and in Dermatology | |
| Product Code | GEX | GEX | Identical |
| Indications for | The ECHOLASER X4 laser | The ECHOLASER X4 laser | Comparable, do not raise |
| Use | system is indicated for use | system is intended for use in | different questions of safety |
| | to necrotize or coagulate | cutting, vaporization, ablation | and effectiveness since the |
| | tissue<br>through<br>soft | and coagulation of soft tissue | intended use are the same. |
| | interstitial irradiation<br>in | in conjunction with | |
| | medicine and surgery in | endoscopic equipment | |
| | cardiovascular<br>thoracic | (including laparoscopes , | |
| | surgery (excluding<br>the | hysteroscopes, | |
| | heart and the vessels in the | bronchoscopes, gastroscopes, | |
| | pericardial<br>sac), | cystoscopes and | |
| | ear-nose-<br>dermatology, | colonoscopies), in | |
| | throat<br>surgery, | incision/excision, | |
| | gastroenterology, general | vaporization, ablation and | |
| | surgery, gynecology, head | coagulation of soft tissue in | |
| | and neck surgery, plastic | contact and non-contact | |
| | orthopedics,<br>surgery, | open surgery (with or without | |
| | pulmonology, radiology, | a handpiece), and in the | |
| | and<br>urology,<br>at<br>a | treatment and/or removal of | |
| | wavelength of 1064nm. | vascular lesions (tumors). | |
| Laser Type | DIODE | DIODE | Identical |
| Wavelength (μm) | 1064 nm ± 10% | 1064 nm ± 10% | Identical |
| Output mode | Multimode | Multimode | Identical |
| Maximum | 28W (up to 7 W for each | 28W (up to 7 W for each laser | Identical |
| delivered Power | laser fiber) | fiber) | |
| Stability of the | ±20% | +20% | Identical |
| output power | | | |
| level | | | |
| Mode of | Continuous wave | Continuous wave | Identical |
| operation | | | |
| Output power | 0.5W | 0.5W | Identical |
| increments | | | |
| Cooling | TEC | TEC | Identical |
| Emission | Controlled by footswitch | Controlled by footswitch | Identical |
| Aiming Beam | Diode | Diode | Identical |
| Laser Type<br>● | 630-670 nm | 630-670 nm | |
| Wavelength<br>● | < 3 mW | < 3 mW | |
| Maximum<br>● | | | |
| Delivered | | | |
| Output Power | | | |
| Output port | SMA 905 | SMA 905 | Identical |
| Introducers | Elesta – El AG2 020 620 | Biopsybell TR2111.9EC | Comparable in material, |
| | Elesta - El AG2 0020 640 | Biopsybell TR2120.8EC | construction, and processing |
| | | | and thus do not raise |
| | | | different questions of safety |
| | | | and effectiveness. |
| Laser Type (per<br>IEC 60825-1) | Class 4 | Class 4 | Identical |
| | Subject Device | Primary Predicate Device | Comments |
| Laser Safety<br>Classification FDA | Class 2 | Class 2 | Identical |
| Power source<br>(General) | 110-120V AC / 50-60Hz | 110-120V AC / 50-60Hz | Identical |
| Operating<br>temperature<br>range | 10°C – 35°C | 10°C – 35°C | Identical |
| Emergency<br>switch | Yes | Yes | Identical |
| Key activation of<br>laser output | Yes | Yes | Identical |
| Remote Interlock | Yes | Yes | Identical |
| Power ON/OFF<br>visual indicator | Yes | Yes | Identical |
| Laser emission<br>Indicator | Yes | Yes | Identical |
| Internal laser<br>power monitor | Yes | Yes | Identical |
| Fiber insertion<br>interlock | Yes | Yes | Identical |
| Audio warning<br>signal level | Fixed at HIGH | Fixed at HIGH | Identical |

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# 7. Non-Clinical Testing

The following non-clinical tests were performed:

i) Biocompatibility assessment per ISO 10993.

No additional non-clinical testing is needed since the subject device is identical to the primary predicate.

# 8. Clinical Testing

No additional clinical testing is needed since the subject device is identical to the primary predicate.

# 9. Conclusions

In light of evidence summarized above and based on classification, intended use, technological characteristics and performance data, the subject device is substantially equivalent to the primary predicate device.