YOUNG AGAIN

K124064 · Espansione Marketing S.P.A · OHS · Dec 19, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K124064
• Device Name: YOUNG AGAIN
• Applicant: Espansione Marketing S.P.A
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Dec 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Young Again is an over the counter device intended to emit energy in the red and IR region of the spectrum for use in dermatology for treatment of periorbital wrinkles.

Device Story

Young Again is an OTC LED-based device for periorbital wrinkle treatment. System consists of a main control unit on a trolley and two facial masks (Red 634nm and IR 830nm). User interacts via touch screen panel to manage treatment time. Device emits light energy to skin; intended for home use by lay persons. Software controls LED emission parameters and treatment duration. Benefits include non-invasive wrinkle reduction.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including energy density and standard dose measurements, and a self-selection/usability study to confirm lay-person understanding and safe operation.

Technological Characteristics

LED-based light therapy device; wavelengths 634nm (Red) and 830nm (IR). System includes main control unit with touch screen and facial masks. Complies with IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993-1. Software-controlled treatment timing.

Indications for Use

Indicated for OTC use in dermatology for the treatment of periorbital wrinkles.

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

• Omnilux New-U (K072459)
• E-Light Line (K092734)
• Silk'n FX (K110301)

Submission Summary (Full Text)

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Espansione Marketing S.p.A. 510(K) Notification

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K124064 Page 1 of 2 DEC 1 9 2013

YOUNG AGAIN

## 510(k) Summary for the Young Again

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

## 2.1.General Information

| Submitter: | Espansione Marketing Spa is located at:<br>Blocco 27 - Via Orefici 152<br>Centergross 40050 Funo - Bologna S.p.A.<br>Italy |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Guido Bonapace<br>ISEMED srl |
| | Via A. Altobelli Bonetti 3/A<br>40026 Imola (BO)<br>Italy<br>Mob.phone: [phone]<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Summary Preparation Date: | December 21, 2012 |
| 2.2. Names | |
| Device Name:<br>Classification Name:<br>Product Code: | Young Again<br>Laser Surgical Instrument for use in General and<br>PlasticSurgery and in Dermatology<br>OHS |

### 2.3. Predicate Devices

Regulation number:

The Young Again is substantially equivalent to the following devices:

| Applicant | Device name | 510(k) Number |
|--------------------------|---------------|---------------|
| Photo Therapeutics Inc. | Omnilux New-U | K072459 |
| Espansione Marketing SPA | E-Light Line | K092734 |
| Home Skinovations LTD | Silk'n FX | K110301 |

878.4810

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K124064 Page 2 of 2

#### 2.4. Device Description

The Young Again is a device which allows emission and treatment with LED light in the RED (634 nm ) and IR (830nm) spectrum. The Young Again devices include a main unit installed on a trolley support, that controls and manages the LED emission through the two facial masks. The facial masks are designed in two versions depending upon the features of the LED installed in the mask: Red or IR The control panel is placed in the main unit with all the circuitry necessary to control the device and the user interacts with the Young Again device through the touch screen panel of the main unit and through a specific software application that allow the precise control of the treatment time.

#### 2.5. Indications for Use

The Young Again is an over the counter device intended to emit energy in the red and IR region of the spectrum for use in dermatology for treatment of periorbital wrinkles.

#### 2.6. Performance Data

In order to evaluate if the lay person could understand, select and use the device, Espansione Marketing has conducted a self-selection and usability test.

The Young Again software was tested and validated in accordance with the FDA "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices".

The Young Again energy densityand the standard dose was measured for the Young Again device with the two Red & IR masks, in a specific performance test. The results of this test allow to confirmthat the performance of the device with its masks are as expected. Furthermore these results were used to compare the technical parameters of the Young Again device to the predicate device Young Again device has been developed and tested according to the following international

standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO , ISO /FDIS 15223-1, and ISO 10993-1 recognized by FDA.

Based upon an analysisof the overall performance technical features in the substantial equivalence discussion for the device, Espansione Marketing believes that no significant differences exist between the previously approved Espansione Marketing devices (E-light line K092734) and the Therapeutics Omnilux New-U (K072459) and Home other predicate devices Photo SkinovationsSilk'n FX (K110301).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

Espansione Marketing Spa % Mr. Guido Bonapace Isemed Srl Via Altobelli Boneti 3A Imola, Bologna 40026 ITALY

December 19, 2013

Re: K124064

Trade/Device Name: Young Again 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: OHS Dated: December 5, 2013 Received: December 11, 2013

Dear Mr. Bonapace:

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. Ilsting 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

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Page 2 - Mr. Guido Bonapace

device-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For 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): K124064

Device Name: Young Again

Indications For Use: The Young Again is an over the counter device intended to emit energy in the red and IR region of the spectrum for use in dermatology for treatment of periorbital wrinkles.

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| Prescription Use | | AND/OR | Over-The-Counter Use | X |
|-----------------------------|--|--------|------------------------|---|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Neil R Ogden | |
|------------------------------|---------|
| 2013.12.17 | |
| (Division Sign-Off) for BSA | |
| Division of Surgical Devices | |
| 510(k) Number | K124064 |

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