SCAR 3

K211362 · El.En Electronic Engineering Spa · GEX · Aug 25, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211362
• Device Name: SCAR 3
• Applicant: El.En Electronic Engineering Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 25, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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, 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 Story

SCAR 3 is an optional scanning unit accessory for DEKA Smartxide family CO2 lasers (10600 nm). It consists of a scanning head and cable. The device directs laser energy to soft tissue to perform ablation, vaporization, excision, and coagulation. Parameters are selected via the host laser's GUI; scanning area shape and size are controlled via keys on the scanning head. Used in clinical settings by physicians for dermatology and plastic surgery procedures. The scanner enables precise laser delivery for skin resurfacing and scar treatment, potentially improving patient outcomes through controlled tissue removal.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including compliance with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1 standards.

Technological Characteristics

Medical laser scanning unit accessory for CO2 lasers. Wavelength: 10600 nm. Pulse energy: 2.5-150 mJ. Spot size: 0.12 mm. Scanning area: max 10x10 mm. Frequency: 150-450 Hz. Pulse duration: 0.1-2.5 ms. Connectivity: connects to DEKA Smartxide family lasers. Complies with IEC 60601-1, 60601-1-2, 60601-2-22, and 60825-1.

Indications for Use

Indicated for soft tissue ablation, vaporization, excision, incision, and coagulation in dermatology and plastic surgery, including laser burn debridement and skin resurfacing for wrinkles, rhytids, furrows, acne scars, and surgical scars.

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

• Lumenis UltraPulse system (K151331)

Submission Summary (Full Text)

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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.

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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-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 ([e-mail]) or phone [phone] 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

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# 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 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, 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) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 12pt;"> <b> <span style="font-family: Symbol;">☑</span> </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 12pt;"> <b> <span style="font-family: Symbol;">☐</span> </b> </span> 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: [phone] E-mail: [e-mail]

#### 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

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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 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

#### 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.

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| Device Trade<br>Name | Subject Device | Predicate Device | Comment |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| | SCAR 3 used in conjunction with<br>DEKA Smartxide family | K151331<br>UltraPulse system with Deep FX/Scaar FX | |
| Indications<br>for Use | The SCAR 3 scanner, when used with DEKA<br>Smartxide family lasers (K180193), is<br>indicated for ablation, vaporization, excision,<br>incision, and coagulation of soft tissue in<br>dermatology and plastic surgery.<br><br>The SCAR 3 scanner, when used with DEKA<br>Smartxide family lasers (K180193), is<br>indicated for use in the performance of<br>specific applications in dermatology and<br>plastic surgery as follows:<br><br>-The ablation, vaporization, excision, incision,<br>and coagulation of soft tissue in the<br>performance of laser burn debridement<br><br>-Laser skin resurfacing (ablation and/or<br>vaporization) for treatment of: | The UltraPulse system (UltraPulse and UltraPulse DUO models, members of the<br>modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for<br>use in surgical applications requiring the ablation, vaporization, excision, incision, and<br>coagulation of soft tissue in medical specialties including: aesthetic (dermatology and<br>plastic surgery), [...].<br><br>The UltraPulse system (UltraPulse and UltraPulse DUO models, members of the<br>modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for<br>use in the performance of specific surgical applications in aesthetic (dermatology and<br>plastic surgery), [...] as follows:<br><br>Dermatology & Plastic Surgery<br><br>-The ablation, vaporization, excision, incision, and coagulation of soft tissue in<br>dermatology and plastic surgery in the performance of:<br>• [...]<br>• Laser burn debridement<br><br>-Laser skin resurfacing (ablation and/or vaporization) for treatment of: | Subject<br>device's<br>indications<br>for use are<br>a subset of<br>the<br>predicate<br>device's |
| Device Trade<br>Name | Subject Device | Predicate Device | Comment |
| | SCAR 3 used in conjunction with<br>DEKA Smartxide family | K151331<br>UltraPulse system with Deep FX/Scaar FX | |
| | • Wrinkles, rhytids, and furrows (including<br>fine lines and texture irregularities) | • Wrinkles, rhytids, and furrows (including fine lines and texture irregularities). | |
| | -Laser skin resurfacing (ablation and/or<br>vaporization) of soft tissue for the reduction,<br>removal, and/or treatment of: | -Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction,<br>removal, and/or treatment of: | |
| | • Acne scars | • [...] | |
| | • Surgical scars | • Acne scars | |
| | | • Surgical scars | |
| | | [...] | |
| | | (For more indications see K151331 IFU statement) | |
| Product<br>code and<br>regulation | GEX<br>ONG<br>21 CFR 878.4810 | GEX<br>ONG<br>21 CFR 878.4810 | |
| Laser<br>Wavelength | 10600 nm | 10600 nm | Identical |
| Pulse Energy | 2.5-150 mJ | 2.5-150 mJ | Identical |
| Device Trade<br>Name | Subject Device | Predicate Device | Comment |
| | SCAR 3 used in conjunction with<br>DEKA Smartxide family | K151331<br>UltraPulse system with Deep FX/Scaar FX | |
| Spot Sizes | 0.12 mm | 0.12 mm | Identical |
| Pulse<br>Duration | 0.1-2.5 ms | Not available | Data not<br>available for<br>predicate<br>device |
| Scanning<br>Area | Max 10*10 mm | Max 10*10 mm | Identical |
| Density<br>(spots per<br>scan %) | 1%-25 % | 1%-25 % | Identical |
| Frequency<br>(Hz) | 150-450 | 150-400 | Similar.<br>Minor<br>differences<br>in maximum<br>frequencies<br>do not affect<br>safety and<br>effectiveness<br>of the device |

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

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#### 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.