K Number

Device Name

SCAR 3

Manufacturer

EL. En Electronic Engineering SPA

Date Cleared

2021-08-25

(114 days)

Product Code

GEX

Regulation Number

878.4810

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K151331

Reference Devices

K180193

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser scanner accessory with manual controls for shape and size, and parameter selection through the connected laser device's GUI. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

Yes
The device is indicated for specific applications in dermatology and plastic surgery, including laser skin resurfacing for wrinkles and various types of scar treatment, which are typically defined as therapeutic interventions. Furthermore, the IEC 60601-2-22 standard, with which the device complies, specifically mentions "therapeutic" laser equipment.

Diagnostic

The device description and intended use clearly state that the SCAR 3 scanner, when used with DEKA Smartxide family lasers, is indicated for various surgical procedures involving ablation, vaporization, excision, incision, and coagulation of soft tissue. It is designed for treatment (e.g., laser skin resurfacing, burn debridement) rather than for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description explicitly states that the SCAR 3 is composed of physical components: a "HiScan SCAR 3 head" and a "HiScan SCAR 3 cable." It also mentions physical keys on the scanning head for selecting parameters. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the SCAR 3 scanner is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
SCAR 3 Function: The SCAR 3 scanner is a surgical accessory used with a laser to directly interact with soft tissue on the patient's body for procedures like ablation, vaporization, and excision. It does not analyze specimens taken from the body.
Intended Use: The intended use clearly describes surgical procedures performed directly on the patient's skin and soft tissue.
Device Description: The description details a scanning unit that directs laser energy, not a device for analyzing biological samples.

Therefore, the SCAR 3 scanner falls under the category of a surgical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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

Product codes (comma separated list FDA assigned to the subject device)

GEX, ONG

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.

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

Not Found

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)

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.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K151331

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K180193

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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.

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

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)

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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

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.

| Device Trade

Name	Subject Device	Predicate Device	Comment
	SCAR 3 used in conjunction with
DEKA Smartxide family	K151331
UltraPulse system with Deep FX/Scaar FX
Indications
for Use	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: | The UltraPulse system (UltraPulse and UltraPulse DUO models, members of the
modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for
use in surgical applications requiring the ablation, vaporization, excision, incision, and
coagulation of soft tissue in medical specialties including: aesthetic (dermatology and
plastic surgery), [...].

The UltraPulse system (UltraPulse and UltraPulse DUO models, members of the
modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for
use in the performance of specific surgical applications in aesthetic (dermatology and
plastic surgery), [...] as follows:

Dermatology & Plastic Surgery

-The ablation, vaporization, excision, incision, and coagulation of soft tissue in
dermatology and plastic surgery in the performance of:
• [...]
• Laser burn debridement

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

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.