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.

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.

AI/ML Overview

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification from the FDA for the ECHOLASER X4, which is a laser surgical instrument. It details the device's indications for use, its substantial equivalence to a predicate device (K181510), and the fact that the requested change is solely a language revision of the intended use, supported by a reference predicate (K181859).

Since the submission states that no other changes have been made to the existing ECHOLASER X4 and that the technical features, design, performance, and safety are unaffected, no new non-clinical or clinical testing was performed to demonstrate performance against acceptance criteria. The submission relies on the prior clearance of the predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about studies, sample sizes, ground truth, experts, or adjudication methods, as this information is not present in the provided text.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

{3}------------------------------------------------

510(k) Summary

1. General Information

Applicant:

ELESTA SpA Via Baldanzese, 17 Calenzano (FI) Italy 50041, Italy Tel. +39 055 8826807 Fax +39 055 7766698

Establishment Registration Number: 3015077548

Contact for the application:	Maurizio Pantaleoni
	Via Borgo Santa Cristina 12
	Imola (BO) 40026, Italy
	Tel. +39 3484435155
	Email: maurizio.pantaleoni@gmail.com

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. ELECTRONICENGINEERING SPA	ECHOLASER X4	K181510
Reference	Medtronic Navigation Inc.	Visualase Thermal Therapy System	K181859

{4}------------------------------------------------

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

5. Indications for Use

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, LaserSurgical Instrument for	21 CFR§878.4810, LaserSurgical Instrument for Use in	Identical
	Subject Device	Primary Predicate Device	Comments
	Use in General and PlasticSurgery and inDermatology	General and Plastic Surgeryand 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
	tissuethroughsoft	and coagulation of soft tissue	intended use are the same.
	interstitial irradiationin	in conjunction with
	medicine and surgery in	endoscopic equipment
	cardiovascularthoracic	(including laparoscopes ,
	surgery (excludingthe	hysteroscopes,
	heart and the vessels in the	bronchoscopes, gastroscopes,
	pericardialsac),	cystoscopes and
	ear-nose-dermatology,	colonoscopies), in
	throatsurgery,	incision/excision,
	gastroenterology, general	vaporization, ablation and
	surgery, gynecology, head	coagulation of soft tissue in
	and neck surgery, plastic	contact and non-contact
	orthopedics,surgery,	open surgery (with or without
	pulmonology, radiology,	a handpiece), and in the
	andurology,ata	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●	630-670 nm	630-670 nm
Wavelength●	< 3 mW	< 3 mW
Maximum●
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 (perIEC 60825-1)	Class 4	Class 4	Identical
	Subject Device	Primary Predicate Device	Comments
Laser SafetyClassification FDA	Class 2	Class 2	Identical
Power source(General)	110-120V AC / 50-60Hz	110-120V AC / 50-60Hz	Identical
Operatingtemperaturerange	10°C – 35°C	10°C – 35°C	Identical
Emergencyswitch	Yes	Yes	Identical
Key activation oflaser output	Yes	Yes	Identical
Remote Interlock	Yes	Yes	Identical
Power ON/OFFvisual indicator	Yes	Yes	Identical
Laser emissionIndicator	Yes	Yes	Identical
Internal laserpower monitor	Yes	Yes	Identical
Fiber insertioninterlock	Yes	Yes	Identical
Audio warningsignal level	Fixed at HIGH	Fixed at HIGH	Identical

{5}------------------------------------------------

{6}------------------------------------------------

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.

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.