The SCAR 3 scanner, when used with DEKA Smartxide family lasers (K180193), is indicated for ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery.

The SCAR 3 scanner, when used with DEKA Smartxide family lasers (K180193), is indicated for use in the performance of specific applications in dermatology and plastic surgery as follows:

-The ablation, vaporization, excision, incision, and coagulation of soft tissue in the performance of laser burn debridement

-Laser skin resurfacing (ablation and/or vaporization) for treatment of:

· Wrinkles, rhytids, and furrows (including fine lines and texture irregularities)

-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:

Acne scars
· Surgical scars

Device Description

The SCAR 3 scanning unit is an optional scanner that can be connected to the Deka SmartXide family lasers (K180193).

The SCAR 3 is composed of the following components:

HiScan SCAR 3 head
HiScan SCAR 3 cable

Laser emission parameters are selected through the GUI of the DEKA laser device to whom the scanner is connected.

Shape and size of the scanning area may also be selected by using the three keys on the scanning head.

AI/ML Overview

This document is a 510(k) summary for the SCAR 3 scanner, a medical laser scanning unit. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria. Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here is the information that can be extracted, acknowledging the limitations of the document's purpose:

1. Table of acceptance criteria and the reported device performance

The document does not present specific quantitative acceptance criteria or detailed device performance metrics in a readily extractable table format for clinical efficacy. Instead, it relies on demonstrating substantial equivalence to a predicate device by comparing indications for use, principle of operation, and technological characteristics.

Feature	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (SCAR 3)
Indications for Use	Ability to perform ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, including specific applications like laser burn debridement, laser skin resurfacing for wrinkles, rhytids, furrows, fine lines, texture irregularities, acne scars, and surgical scars.	The SCAR 3 scanner, when used with DEKA Smartxide family lasers, is indicated for ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery. It is also indicated for laser burn debridement, laser skin resurfacing for wrinkles, rhytids, furrows (including fine lines and texture irregularities), acne scars, and surgical scars. (Stated as a subset of the predicate's indications).
Laser Wavelength	10600 nm	10600 nm
Pulse Energy	2.5-150 mJ	2.5-150 mJ
Spot Sizes	0.12 mm	0.12 mm
Scanning Area	Max 10*10 mm	Max 10*10 mm
Density (spots per scan %)	1%-25%	1%-25%
Pulse Duration	Data not available for predicate device (Implied acceptable performance based on overall clinical safety/efficacy of predicate)	0.1-2.5 ms
Frequency (Hz)	150-400 Hz	150-450 Hz (Described as "Similar. Minor differences in maximum frequencies do not affect safety and effectiveness of the device.")
Safety and Performance	Compliance with relevant medical device and laser safety standards (e.g., IEC 60601-1, IEC 60825-1).	The SCAR 3 was tested and found in compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1. This ensures its basic safety and essential performance, and electromagnetic compatibility.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states "Clinical Performance Data: None." and discusses "Non-Clinical Performance Data." Therefore, there is no test set in the context of clinical performance data used for this submission. The non-clinical performance data consisted of testing against recognized standards (see point 1 and 8).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical performance study with a test set requiring expert-established ground truth was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical performance study with a test set requiring adjudication was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a laser scanning unit, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical laser scanning unit, not an algorithm. Performance was evaluated through non-clinical testing against standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance testing (compliance with standards), the "ground truth" was compliance with the specified requirements and criteria outlined in the standards (e.g., electrical safety limits, electromagnetic compatibility limits, laser safety classifications). This is determined by engineering measurements and tests.

8. The sample size for the training set

Not applicable, as no clinical performance or machine learning study involving a training set was conducted for this submission. The device is a physical medical instrument.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 25, 2021

EL. En Electronic Engineering SPA Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50041 Italy

Re: K211362

Trade/Device Name: Scar 3 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 28, 2021 Received: May 3, 2021

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/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-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.

Purva Pandya 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) K211362

Device Name SCAR 3

Indications for Use (Describe)

The SCAR 3 scanner, when used with DEKA Smartxide family lasers (K180193), is indicated for use in the performance of specific applications in dermatology and plastic surgery as follows:

-The ablation, vaporization, excision, and coagulation of soft tissue in the performance of laser burn debridement

-Laser skin resurfacing (ablation and/or vaporization) for treatment of:

· Wrinkles, rhytids, and furrows (including fine lines and texture irregularities)

-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:

Acne scars
· Surgical scars

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.

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

K211362 - SCAR 3 SCANNER FOR DEKA SMARTXIDE FAMILY LASERS

Submitter:

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

Contact:

Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it

Date Summary Prepared:

August 23, 2021

Device Trade Name:

SCAR 3

Common Name:

Medical laser scanning unit

Classification Name:

Powered laser surgical instrument (GEX) Powered Laser Surgical Instrument With Microbeam\Fractional Output (ONG)

Classification Number:

21 CFR 878.4810

Predicate Devices:

Lumenis UltraPulse system (K151331)

Device Description:

The SCAR 3 scanning unit is an optional scanner that can be connected to the Deka SmartXide family lasers (K180193).

The SCAR 3 is composed of the following components:

HiScan SCAR 3 head
HiScan SCAR 3 cable

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

Laser emission parameters are selected through the GUI of the DEKA laser device to whom the scanner is connected.

Shape and size of the scanning area may also be selected by using the three keys on the scanning head.

Indications for Use:

The SCAR 3 scanner, when used with DEKA Smartxide family lasers (K180193), is indicated for use in the performance of specific applications in dermatology and plastic surgery as follows:

-The ablation, vaporization, excision, incision, and coagulation of soft tissue in the performance of laser burn debridement

-Laser skin resurfacing (ablation and/or vaporization) for treatment of:

· Wrinkles, rhytids, and furrows (including fine lines and texture irregularities)
-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
Acne scars
· Surgical scars

Substantial equivalence discussion:

The SCAR 3 scanner when used with DEKA Smartxide family (cleared with K180193) is substantially equivalent to a legally marketed device: the UltraPulse system (K151331). Specifically, the SCAR 3 scanner when used with DEKA Smartxide family is equivalent to Ultrapulse system equipped with Deep FX/Scaar FX scanning unit.

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

Device TradeName	Subject Device	Predicate Device	Comment
	SCAR 3 used in conjunction withDEKA Smartxide family	K151331UltraPulse system with Deep FX/Scaar FX
Indicationsfor Use	The SCAR 3 scanner, when used with DEKASmartxide family lasers (K180193), isindicated for ablation, vaporization, excision,incision, and coagulation of soft tissue indermatology and plastic surgery.The SCAR 3 scanner, when used with DEKASmartxide family lasers (K180193), isindicated for use in the performance ofspecific applications in dermatology andplastic surgery as follows:-The ablation, vaporization, excision, incision,and coagulation of soft tissue in theperformance of laser burn debridement-Laser skin resurfacing (ablation and/orvaporization) for treatment of:	The UltraPulse system (UltraPulse and UltraPulse DUO models, members of themodified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated foruse in surgical applications requiring the ablation, vaporization, excision, incision, andcoagulation of soft tissue in medical specialties including: aesthetic (dermatology andplastic surgery), [...].The UltraPulse system (UltraPulse and UltraPulse DUO models, members of themodified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated foruse in the performance of specific surgical applications in aesthetic (dermatology andplastic surgery), [...] as follows:Dermatology & Plastic Surgery-The ablation, vaporization, excision, incision, and coagulation of soft tissue indermatology and plastic surgery in the performance of:• [...]• Laser burn debridement-Laser skin resurfacing (ablation and/or vaporization) for treatment of:	Subjectdevice'sindicationsfor use area subset ofthepredicatedevice's
Device TradeName	Subject Device	Predicate Device	Comment
	SCAR 3 used in conjunction withDEKA Smartxide family	K151331UltraPulse system with Deep FX/Scaar FX
	• Wrinkles, rhytids, and furrows (includingfine lines and texture irregularities)	• Wrinkles, rhytids, and furrows (including fine lines and texture irregularities).
	-Laser skin resurfacing (ablation and/orvaporization) of soft tissue for the reduction,removal, and/or treatment of:	-Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction,removal, and/or treatment of:
	• Acne scars	• [...]
	• Surgical scars	• Acne scars
		• Surgical scars
		[...]
		(For more indications see K151331 IFU statement)
Productcode andregulation	GEXONG21 CFR 878.4810	GEXONG21 CFR 878.4810
LaserWavelength	10600 nm	10600 nm	Identical
Pulse Energy	2.5-150 mJ	2.5-150 mJ	Identical
Device TradeName	Subject Device	Predicate Device	Comment
	SCAR 3 used in conjunction withDEKA Smartxide family	K151331UltraPulse system with Deep FX/Scaar FX
Spot Sizes	0.12 mm	0.12 mm	Identical
PulseDuration	0.1-2.5 ms	Not available	Data notavailable forpredicatedevice
ScanningArea	Max 10*10 mm	Max 10*10 mm	Identical
Density(spots perscan %)	1%-25 %	1%-25 %	Identical
Frequency(Hz)	150-450	150-400	Similar.Minordifferencesin maximumfrequenciesdo not affectsafety andeffectivenessof the device

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

{7}------------------------------------------------

The SCAR 3 indications for use are a subset of the above mentioned predicate device's, with same principle of operation and similar performances.

{8}------------------------------------------------

Clinical Performance Data:

None.

Non-Clinical Performance Data:

The SCAR 3 was tested and found in compliance 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 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -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:

Based on the comparison of indications for use and the technological characteristics, and on the outcome of non-clinical performance data provided, we can conclude that SCAR 3 scanner is as safe, as effective, and performs as well as the legally marketed 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.