DEKA SMARTXIDE TOUCH

K172362 · El.En Electronic Engineering Spa · GEX · Nov 17, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K172362
• Device Name: DEKA SMARTXIDE TOUCH
• Applicant: El.En Electronic Engineering Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Incision, excision, ablation, vaporization, and coagulation of body soft tissue including intraoral tissue, in medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Device Story

DEKA SMARTXIDE TOUCH is a 10.6μm CO2 laser system (max 40W) for soft tissue surgery and skin resurfacing. Laser energy is delivered via an articulated arm with seven mirrors to a handpiece or the HiScan DOT+ scanning unit. Operated by clinicians in clinical settings; device provides precise tissue ablation, excision, and vaporization. Output is controlled by the physician to achieve desired clinical outcomes in aesthetic, surgical, and dental procedures. Benefits include controlled tissue interaction for surgical and resurfacing applications.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical performance testing, including conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1 standards.

Technological Characteristics

10.6μm CO2 laser source; max power 40W. Delivery via articulated arm with seven rotating mirrors. Includes HiScan DOT+ scanning unit for skin resurfacing. Conforms to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-22 (laser surgical equipment), and IEC 60825-1 (laser safety).

Indications for Use

Indicated for incision, excision, ablation, vaporization, and coagulation of soft tissue in patients requiring surgical intervention in dermatology, plastic surgery, ENT, gynaecology, neurosurgery, dental/oral surgery, and genitourinary surgery. Scanning unit indicated for ablative skin resurfacing.

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

• AFFIRM CO2 and AFFIRM CO2 HP laser system (K081424)

Submission Summary (Full Text)

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November 17, 2017

ELEN Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, 50041 Italy

Re: K172362

Trade/Device Name: Deka Smartxide Touch 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: August 22, 2017 Received: August 24, 2017

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Jennifer R. Stevenson -53

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

K172362

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name DEKA SMARTXIDE TOUCH

Indications for Use (Describe)

Incision, excision, ablation, vaporization of body soft tissue including intraoral tissue, in medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

| Type of Use (Select one or both, as applicable) | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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### 510(K) Summary

# DEKA SMARTXIDE TOUCH

## 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 2, 2017

Device Trade Name: DEKA SMARTXIDE TOUCH

# Common Name:

Medical Laser system

### Classification Name:

Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology (GEX)

### Classification Number:

21 CFR 878.4810

# Equivalent Devices:

AFFIRM CO2 and AFFIRM CO2 HP laser system (K081424).

# Device Description:

The DEKA SMARTXIDE TOUCH is a medical device equipped with a 10.600 nm Carbon Dioxide (CO2) laser source having a maximum power of 40W. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation. The DEKA SMARTXIDE TOUCH laser is equipped with a Scanning Unit, HiScan DOT+, that allows to perform skin resurfacing treatments.

### Intended Use:

Incision, excision, ablation, vaporization, and coagulation of body soft tissue including intraoral tissue, in medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

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### Substantial equivalence discussion:

The DEKA SMARTXIDE TOUCH is substantially equivalent to the AFFIRM CO2 and AFFIRM CO2 HP laser systems (K081424).

| Device Trade<br>Name | DEKA SMARTXIDE<br>TOUCH | Predicate Device<br>AFFIRM CO2 and<br>AFFIRM CO2 HP<br>K081424 |
|-------------------------------|-------------------------|----------------------------------------------------------------|
| Laser Type | CO2 | CO2 |
| Wavelength | 10.6μm | 10.6μm |
| Max Power | 40W | 25W<br>60W (HP) |
| Handpieces<br>Spot Sizes | 0.2 mm, 0.4 mm | 0.2 mm, 0.4 mm |
| Pulse Duration | 0.02 to 70 ms | 0.2 to 80 ms |
| Pulse Rep Rate | 5 to 100 Hz | 5 to 100 Hz |
| Scanner Spot<br>size | 350μm | 350μm |
| Scanner Focal<br>length (EFL) | 100mm | 100mm |

The DEKA SMARTXIDE TOUCH has the same indications for use as the abovementioned predicate device, with same principle of operation and essentially the same performances.

### Clinical Performance Data:

None

### Non-Clinical Performance Data:

The DEKA SMARTXIDE TOUCH was tested for standards conformance with the following standards:

IEC 60601-1- Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - 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:

We can conclude that the DEKA SMARTXIDE TOUCH laser system is substantially equivalent to the predicate device .

### Additional Information:

None