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 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
Led Body Band
Led Masks
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
Evoluzione Plus
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.

AI/ML Overview

The provided document is a 510(k) summary for the E-light Line of devices (IPL, LED and Vacuum equipment for dermatological use). It outlines the device's general information, predicate devices, device description, indications for use, and a statement of substantial equivalence.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

No specific acceptance criteria or a dedicated study proving the device meets those criteria are explicitly reported in this 510(k) summary.

The document states: "No clinical study was been submitted." Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices. This means that the manufacturer is arguing that their device is as safe and effective as existing devices because it has the same intended use, similar technological characteristics, and similar applications, and no significant differences exist.

Therefore, the requested table of acceptance criteria and reported device performance cannot be generated directly from this document, as a formal performance study with predefined acceptance criteria is not presented. Similarly, most of the specific questions regarding sample sizes, ground truth establishment, expert qualifications, and adjudication methods are not applicable because clinical performance studies were not performed or submitted.

Here's what can be extracted and inferred regarding your request:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or formal performance data tied to specific metrics (e.g., sensitivity, specificity, accuracy for an AI device) are reported for the clinical effectiveness of the E-light Line. The submission focuses on substantial equivalence to predicate devices.

The only "performance data" mentioned are successful passes of electrical safety and electromagnetic compatibility tests:

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with EN 60601-1:2004 (Electrical Safety)	Passed
Compliance with IEC 60601-1-2:2004 (Electromagnetic Compatibility)	Passed
Compliance with EN 980:2004 (Graphical Symbols)	Developed according to
Compliance with EN ISO 14971:2007 (Risk Management)	Developed according to

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set or data provenance is reported as "No clinical study was been submitted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. No clinical test set or ground truth establishment is reported.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication method is reported.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No MRMC study was done, as "No clinical study was been submitted." This device also does not appear to be an AI-driven device intended to assist human readers; it is a physical medical device (IPL, LED, Vacuum).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device. "No clinical study was been submitted."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No clinical ground truth was established as "No clinical study was been submitted."

8. The sample size for the training set

Not applicable. No training set is mentioned as "No clinical study was been submitted."

9. How the ground truth for the training set was established

Not applicable. No ground truth for a training set was established as "No clinical study was been submitted."

Summary Conclusion:

The provided 510(k) summary for the E-light Line demonstrates substantial equivalence by comparing its intended use, technological characteristics, and applications to several predicate devices. It relies on compliance with electrical safety and electromagnetic compatibility standards, along with recognized international standards for medical devices. It explicitly states that "No clinical study was been submitted," meaning there is no information in this document about specific acceptance criteria related to a clinical performance study, nor any data from such a study. Therefore, most of the detailed information requested regarding clinical performance evaluation, sample sizes, ground truth, and expert involvement is not present.

Summary

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Image /page/0/Picture/0 description: The image shows a black and white logo. The logo appears to be a stylized design that incorporates geometric shapes and letterforms. On the left side, there is a circle with a white triangle inside. The right side of the logo features a stylized letter 'e'.

K 092734

ESPANSIONE MARKETING S.P.A.

Blocco 27 Via Orefici 152
Centergross 40050 Funo BOLOGNA - ITALY
Tel. +39 051 8901611 Fax +39 051 863400

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: +39-335-5378686 Telephone: +39-051-6527315 Fax: +39-051-6284344 Email: gbonapace@isemed.eu

Summary Preparation Date:

August 28, 2009

1. 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:

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Image /page/1/Picture/0 description: The image shows a logo that appears to be a stylized representation of the letters 'ae' or a symbol resembling an infinity sign with a pointed element on the left side. The logo is black and white, with the shapes defined by solid black areas against a white background. The design is simple and modern, with clean lines and a bold appearance.

ESPANSIONE MARKETING S.P.A.

Blocco 27 Via Orefici 152
Centergross 40050 Funo BOLOGNA - ITALY
Tel. +39 051 8901611 Fax +39 051 863400
info@espansione.it
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

IPL handpiece
Led handpiece
이 Led Body Band
0 Led Masks

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).

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Blocco 27 Via Orefici 152
Centergross 40050 Funo BOLOGNA - ITALY
Tel. +39 051 8901611 Fax +39 051 863400
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:

· 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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Image /page/3/Picture/0 description: The image shows a logo that appears to be a stylized representation of the letters 'de'. The 'd' is formed by a circle with a triangle cut out of it, and the 'e' is a simple, sans-serif letter. The logo is black and white, and the overall design is modern and minimalist. The logo is likely used to represent a company or organization with a name that starts with the letters 'de'.

ESPANSIONE MARKETING S.P.A.

Blocco 27 Via Drefici 152

Centergross 40050 Funo BOLOGNA - ITALY

Tel. +39 051 8901611 Fax +39 051 863400

info@espansione.it

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 (800) 638-2041 or (301) 796-7100 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

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.