DEKA MOTUS AX

K162886 · El.En Electronic Engineering Spa · GEX · Jun 19, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K162886
• Device Name: DEKA MOTUS AX
• Applicant: El.En Electronic Engineering Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Temporary hair reduction. Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime, on all skin types (Fitzpatrick I - VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

Device Story

DEKA Motus AX is a 755nm Alexandrite solid-state laser system for dermatological applications. Device delivers laser energy via user-replaceable optical fibers and interchangeable handpieces with electronic spot recognition. Activation occurs via footswitch or fingerswitch. System includes integrated skin cooling in the Moveo handpiece; external cooling is optional for other handpieces. Operated by clinicians in a professional setting. Laser energy targets melanin in hair follicles or vascular/pigmented structures to achieve therapeutic effects (hair reduction, photocoagulation, wrinkle treatment). Output allows clinicians to perform precise dermatological procedures; benefits include stable long-term hair reduction and treatment of various skin lesions.

Clinical Evidence

No clinical data provided. Evidence consists of non-clinical bench testing, including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1 standards conformance. Ex-vivo performance data on three tissue types demonstrated comparable thermal energy distribution and tissue effects to the predicate device. Biocompatibility testing was performed on the Moveo handpiece tip.

Technological Characteristics

755nm Alexandrite solid-state laser; 0.25-300 ms pulse duration; up to 10 Hz repetition rate; 2.5-20mm spot sizes. Features electronic spot recognition handpieces. Integrated skin cooling (Moveo handpiece) or optional external cooling. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1. Biocompatible patient-contacting tips.

Indications for Use

Indicated for temporary or permanent hair reduction on all skin types (Fitzpatrick I-VI) including tanned skin, treatment of benign pigmented lesions, treatment of wrinkles, and photocoagulation of benign dermatological vascular lesions (e.g., port-wine stains, hemangiomas, telangiectasias).

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

• DEKA Synchro Repla: Y family of laser systems (K150516)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 19, 2017

El.En. Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 50041 Calenzano (FI), Italy

Re: K162886

Trade/Device Name: DEKA Motus AX 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: May 15, 2017 Received: May 18, 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Jennifer R. Stevenson -S3

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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## Indications for Use

510(k) Number (if known) K162886

Device Name DEKA Motus AX

Indications for Use (Describe)

The DEKA Motus AX laser system is indicated for:

Temporary hair reduction.

Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime, on all skin types (Fitzpatrick I - VI) including tanned skin. Treatment of benign pigmented lesions.

Treatment of wrinkles.

Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) Summary DEKA Motus AX

#### 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:

June 19th, 2017

## Device Trade Name:

DEKA Motus AX

## 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

## Predicate Devices:

DEKA Synchro Repla: Y family of laser systems (K150516).

## Device Description:

The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source. The laser source delivers the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. Handpiece activation is either by footswitch or fingerswitch.

## Intended Use:

Temporary hair reduction.

Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6,9, and 12 months after the completion of a treatment regime, on all skin types (Fitzpatrick I - VI) including tanned skin.

Treatment of benign pigmented lesions.

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#### Treatment of wrinkles. Photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

# Substantial equivalence discussion:

The DEKA Motus AX is substantially equivalent to the 755nm laser source of the DEKA Synchro Repla: Y family of laser systems (K150516).

| Device Trade<br>Name | DEKA Motus AX | Predicate Device<br>K150516<br>DEKA Synchro Repla: Y family of<br>laser systems<br>(755nm laser source) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Laser Type | Alexandrite | Alexandrite |
| Wavelength | 755 nm | 755 nm |
| Max Fluence | 2.5mm handpicece: 600J/cm2<br>5mm handpicece: 160J/cm2<br>7mm handpicece: 80J/cm2<br>10mm handpicece: 40J/cm2<br>12mm handpicece: 27J/cm2<br>14mm handpicece: 20J/cm2<br>15mm handpicece: 17J/cm2<br>16mm handpicece: 15J/cm2<br>18mm handpicece: 12J/cm2<br>20mm handpicece: 10J/cm2<br>Mõveõ handpicece:8J/cm2 | 2.5mm handpicece: 600J/cm2<br>5mm handpicece: 160J/cm2<br>7mm handpicece: 80J/cm2<br>10mm handpicece: 40J/cm2<br>12mm handpicece: 27J/cm2<br>14mm handpicece: 20J/cm2<br>15mm handpicece: 17J/cm2<br>16mm handpicece: 15J/cm2<br>18mm handpicece: 12J/cm2<br>20mm handpicece: 10J/cm2<br>22mm handpicece: 16J/cm2<br>24mm handpicece: 14J/cm2 |
| Spot Sizes | 2.5 to 20mm | 2.5 to 24mm |
| Pulse Duration | 0.25 to 300 ms | 0.25 to 300 ms |
| Pulse Rep Rate | up to 10 Hz | up to 10 Hz |
| Skin Cooling<br>System | Yes, integrated in the Moveo<br>handpiece, external optional for the<br>other handpieces | Yes, optional, integrated by<br>Smartcooler handpiece or external. |

The DEKA Motus AX has the same indications for use as the above mentioned predicate device, with same principle of operation and essentially the same performances.

# Clinical Performance Data:

None

# Non-Clinical Performance Data:

The DEKA Motus AX 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.

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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.

Moreover, ex-vivo performance data on three different tissue types were submitted in order to show that DEKA Motus AX produces comparable thermal energy distribution and adversely affected tissue region as the predicate for the range of energy deposition parameters from the subject and predicate devices for the worst-case deposition time.

Finally, biocompatibility tests have been performed on the Moveo handpiece tip, which comes in contact with the patient.

## Conclusion:

Based on the outcome of non-clinical performance data performed, we can conclude that the DEKA Motus AX laser system is substantially equivalent to the predicate device .

#### Additional Information:

None