E-LIGHT LINE

K092734 · Espansione Marketing S.P.A · GEX · Sep 20, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K092734
• Device Name: E-LIGHT LINE
• Applicant: Espansione Marketing S.P.A
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The E-Light Line devices are intended for dermatological use by physicians and healthcare professionals as the following: IPL Technology is intended for: · Treatment of Acne (from 390 to 1200nm filter) · Treatment of vascular and benign pigmented lesions, cutaneous lesions including warts, scars, striae , and facial and leg veins (from 550 to 1200nm filter). · Removal of unwanted hair in all skin types (from 570- to 1200nm filter) LED Technology is intended: · Yellow LED 594 nm for treatment of periorbital wrinkles and rhytides · Blue LED 428nm to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris · Red LED 632nm for treatment of superficial, benign vascular and pigmented lesions VACUUM Technology is intended to: · Improve Lymphatic circulation in the treated area

Device Story

E-Light Line is a multi-technology dermatological system comprising a main control unit and interchangeable handpieces for IPL, LED, and vacuum therapy. The main unit manages power, capacitor charging, and electronic control. IPL handpieces emit light (390-1200nm) for hair removal, acne, and vascular/pigmented lesions. LED handpieces provide specific wavelengths (Yellow 594nm, Blue 428nm, Red 632nm) for wrinkles, acne, and skin lesions. Vacuum handpieces provide aspiration for lymphatic circulation. Operated by physicians and healthcare professionals in clinical settings. Only one output source functions at a time. System aids clinical decision-making by providing targeted energy-based therapies for various dermatological conditions, potentially improving patient skin appearance and lymphatic health.

Clinical Evidence

No clinical study was submitted. Evidence is based on bench testing, including electrical safety (EN 60601-1:2004) and electromagnetic compatibility (IEC 60601-1-2:2004) testing, and comparison of technical specifications to predicate devices.

Technological Characteristics

System includes main control unit with microcontroller and capacitor charge system. Handpieces: IPL (390-1200nm), LED (Yellow 594nm, Blue 428nm, Red 632nm), and Vacuum. Standards: EN 60601-1 (safety), IEC 60601-1-2 (EMC), EN 980 (symbols), EN ISO 14971 (risk management).

Indications for Use

Indicated for dermatological use by physicians and healthcare professionals for acne treatment, vascular/pigmented lesion removal, wart/scar/striae treatment, hair removal, periorbital wrinkle reduction, and lymphatic circulation improvement.

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

• EPI-C Plus (K070494)
• Photonova Family of pulsed light systems (K073477)
• GentleWaves Led Photomodulation (K031425)
• RevLigth (K042630)
• Ominilux Revive (K030426)
• Ominilux Blue (K030883)
• LEDA (K090762)
• IllumiMed (K060792)
• CELLU M6 Keymodule (K053225)

Submission Summary (Full Text)

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K 092734

**ESPANSIONE MARKETING S.P.A.**

Blocco 27 Via Orefici 152
Centergross 40050 Funo BOLOGNA - ITALY
Tel. [phone] Fax [phone]

SEP 2 0 2010

# 510(k) Summary for the E-Light Line

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

# 1. General Information

Submitter:

Espansione Marketing Spa is located at: Blocco 27 - Via Orefici 152 Centergross 40050 Funo - Bologna ITALY

Contact Person:

Guido Bonapace ISEMED srl Via Borgo Santa Cristina 12 40026 Imola (BO) Italy Mob.phone: [phone] Telephone: [phone] Fax: [phone] Email: [e-mail]

Summary Preparation Date:

August 28, 2009

- 2. Names
Device Family Name: Device models: Common Name: Classification Name:

Product Code: Regulation number:

E-light Line Trinity Plus, EPI-C Plus, Evoluzione Plus IPL, LED and Vacuum equipment II, Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology GEX /ISA 878.4810

### 3. Predicate Devices

The E-light line is substantially equivalent to the following legally marketed device:

1

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**ESPANSIONE MARKETING S.P.A.**

Blocco 27 Via Orefici 152
Centergross 40050 Funo BOLOGNA - ITALY
Tel. [phone] Fax [phone]
[e-mail]
www.espansione.it

| Applicant | Device name | 510(k) Number |
|-----------------------------|------------------------------------------|---------------|
| Espansione Marketing S.p.A. | EPI-C Plus | K070494 |
| Photonova of Sweden AB | Photonova Family of pulsed light systems | K073477 |
| Light BioScience LLC | GentleWaves Led Photomodulation | K031425 |
| Skincare Technology Inc. | RevLigth | K042630 |
| Photo Therapeutics Limited | Ominilux Revive | K030426 |
| Photo Therapeutics Limited | Ominilux Blue | K030883 |
| Quantel Derma Gmbh | LEDA | K090762 |
| PhotoActif LLC | IllumiMed | K060792 |
| LPG One Inc. | CELLU M6 Keymodule | K053225 |

# 4. Device Description

The E-light Line is a family of devices with three types of output emitted from different handpieces. The outputs of the E-light Line are Intense Pulsed Light (IPL), LED and Vacuum. These outputs may be issued from different handpieces. The output handpieces are:

- IPL handpiece
- Led handpiece
- 이 Led Body Band
- 0 Led Masks

r

- Vacuum handpiece
Only one output source works at a time. All the E-Light line devices include a Main Unit that controls and manages the IPL, LED or Vacuum handpiece. The Main Unit contains all circuitry to control the device as the capacitor charge system, the microcontroller and all the electronic parts. The E-light line devices are:

- . Trinity Plus
- l Evoluzione Plus
- l EPI-C Plus

The E-Light Trinity Plus supports all the technologies (IPL, LED and Vacuum) and therefore all the handpieces. The E-Light Evoluzione Plus and EPI-C plus support the IPL and LED Technologies and therefore all the handpiece with the exception of the Vacuum handpieces.

#### 5. Indications for Use

The E-Light Line devices are intended for dermatological use by physicians and healthcare professionals as the following:

IPL Technology is intended for:

- · Treatment of Acne (from 390 to 1200nm filter)
- · Treatment of vascular and benign pigmented lesions, cutaneous lesions including warts, scars, striae , and facial and leg veins (from 550 to 1200nm filter).

2

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Blocco 27 Via Orefici 152
Centergross 40050 Funo BOLOGNA - ITALY
Tel. [phone] Fax [phone]
info@espansione. it

· Removal of unwanted hair in all skin types (from 570- to 1200nm filter) LED Technology is intended:

- · Yellow LED 594 nm for treatment of periorbital wrinkles and rhytides
- · Blue LED 428nm to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris
- · Red LED 632nm for treatment of superficial, benign vascular and pigmented lesions

VACUUM Technology is intended to:

i

- · Improve Lymphatic circulation in the treated area
## 6. Substantial equivalence description

The E-light line is a family of device with difference energy emissions: intense pulsed light (IPL), light emitting diode (LED) and aspiration massager (Vacuum).

The IPL technology is the same of the Espansione Marketing Epi-c Plus (K070494) both for intended use and for technological characteristics, in fact the E-light line family was developed with the same hardware of the Espansione Marketing Epi-c Plus (K070494). The IPL technology is also similar to the Photonova - Photonova Family of pulsed light systems (K073477), in fact the intended use and the emission parameter are very similar to E-light line.

The LED technology is equivalent to the predicate devices K031425 - Light Bioscience LLC -Gentlewaves Led Photomodulation, K042630 - Skincare Technology Inc. - RevLight, K030426 -Photo Therapeutics Limited - Ominilux Revive, K030883 - Photo Therapeutics Limited -Ominilux Blue, K090762 - Quantel Derma Gmbh - LEDA, K060792 - PhotoActif LLC -IllumiMed. The outputs of the Led technology of the E-light line are yellow, red and blue.

The Espansione Marketing E-light line is equivalent to the K031425 - Light Bioscience LLC -Gentlewaves Led Photomodulation and to the K090762 - Quantel Derma Gmbh - LEDA because the E-light line has yellow led with the same wavelength, similar output parameters (energy density, treatment time, dose range), have the same type of application.

The Espansione Marketing E-light line is equivalent to the K030426 - Photo Therapeutics Limited - Ominilux Revive, K042630 - Skincare Technology Inc. - RevLight and to the K090762 -Quantel Derma Gmbh -- LEDA because the E-light line has red led with the same wavelength, similar output parameters (energy density, treatment time, dose range), have the same type of application.

The Espansione Marketing E-light line is equivalent to the K030883 - Photo Therapeutics Limited - Ominilux Blue, the K042630 - Skincare Technology Inc. - RevLight, and to the K060792 -PhotoActif LLC - IllumiMed because the E-light line has red led with the same wavelength, similar output parameters (energy density, treatment time, dose range), have the same body application.

The Vacuum technology is equivalent to LPG One device (K053225). In fact the intended use of the E-light line massager is included in the LPG One device (K053225) intended use. The output parameters of E-light line are included in the LPG One device (K053225) parameters and the method of application is very similar for both devices.

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**ESPANSIONE MARKETING S.P.A.**

Blocco 27 Via Drefici 152

Centergross 40050 Funo BOLOGNA - ITALY

Tel. [phone] Fax [phone]

[e-mail]

www.espansione.it.

Then we believe that the Espansione Marketing E-light line is substantially equivalent to the predicate devices, because it have the same intended use, the similar technology characteristics and the similar application as the predicate devices and no significant differences exists between the predicate devices.

#### 7. Performance Data

The E-Light Line devices have been successfully passed the electric safety tests in accordance with the EN 60601-1:2004 Medical Electrical Equipment - Part 1: General Requirements for Safety and the electromagnetic compatibility tests in accordance with the IEC 60601-1-2:2004 Medical Electrical Equipment - Part 1: General Requirements for Safety; Electromagnetic Compatibility --Requirements and Tests.

The E-Light Line devices have been developed according to the following international standards too:

o EN 980:2004 Graphical symbols for use in the labeling of medical devices

o EN ISO 14971:2007 Medical devices - Application of risk management to medical devices

No clinical study was been submitted.

After an analysis of the indications and intended uses, the technology characteristics, outputs, performance and safety (both electric and electromagnetic), Espansione Marketing believes that no significant differences exist between the predicate devices listed in Section 3, above.

The E-light line 510(k) Summary includes only information that is also covered in the body of the 510(k), it does not contain any puffery or unsubstantiated labeling claims, it does not contain any raw data and contains only summary data, it does not contain any trade secret or confidential commercial information, it does not contain any patient identification information.

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Image /page/4/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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

Espansione Marketing Spa % Isemed S.R.L. Mr. Guido Bonapace Vin Borgo Santa Cristina 12 40026 Imola, Bologna, Italy

SEP 2 0 2010

Re: K092734

Trade/Device Name: E-light Line Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general surgery and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX, ISA, OPA Dated: August 30, 2010 Received: September 01, 2010

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, 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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Page 2 - Mr. Guido Bonapace

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Malkerson

Mark N. Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

E-light Line

SEP 2 0 2010

#### Indications for Use

510(k) Number (if known): K092734

Device Name:

ﻟﺮﻱ ﺍ

E-light Line

Indications for Use:

The E-Light Line devices are intended for dermatological use by physicians and healthcare professionals as the following:

IPL Technology is intended for:

- · Treatment of Acne (from 390 to 1200nm filter)
- · Treatment of vascular and benign pigmented lesions, cutaneous lesions including warts, scars, striae , and facial and leg veins (from 550 to 1200nm filter).
- · Removal of unwanted hair in all skin types (from 570- to 1200nm filter)
- LED Technology is intended:
- · Yellow LED 594 nm for treatment of periorbital wrinkles and rhytides
- · Blue LED 428nm to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris
- · Red LED 632nm for treatment of superficial, benign vascular and pigmented lessons VACUUM Technology is intended to:

· Improve Lymphatic circulation in the treated area

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil Rf. Ryden formten

Division Sign-Of (Division Sign-On)
Division of Surgical, Orthopedic, Division of Storative Devices

510(k) Number K092734

000007