E>EyeC

• K Number: K200616
• Device Name: E>EyeC
• Manufacturer: E-SWIN
• Date Cleared: 2020-06-11 ( 94 days)
• Product Code: ONF GEX ONG
• Regulation Number: 878.4810

Intended Use

The E>Eye is a prescription device intended for the treatment of rosacea.

Device Description

The E>Eye C is an intense pulsed light system composed of a base housing the electric and electronics sub-assemblies, and a handheld piece "applicator" connected to the base by a cord. The applicator contains the source of optical radiation.

Predicate Devices

K170060, K192539

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard intense pulsed light system and does not mention any AI or ML components, image processing, or data sets typically associated with AI/ML development.

Therapeutic

Yes
The device is intended for the treatment of rosacea, which is a medical condition.

Diagnostic

No
The "Intended Use / Indications for Use" section clearly states that the E>Eye is "intended for the treatment of rosacea," indicating it is a therapeutic device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "intense pulsed light system composed of a base housing the electric and electronics sub-assemblies, and a handheld piece 'applicator' connected to the base by a cord." This indicates significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "treatment of rosacea." This is a therapeutic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
• Device Description: The device is an intense pulsed light system that applies light to the patient. This is a physical treatment modality, not a method for analyzing biological samples.
• Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological specimens.

Therefore, the E>Eye is a therapeutic medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The E>Eye is a prescription device intended for the treatment of rosacea.

Product codes (comma separated list FDA assigned to the subject device)

ONF

Device Description

The E>Eye C is an intense pulsed light system composed of a base housing the electric and electronics sub-assemblies, and a handheld piece "applicator" connected to the base by a cord. The applicator contains the source of optical radiation.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

NON-CLINICAL
Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted on the E>EYE C, composed of its base and its applicator/handpiece. The system complies with the IEC 60601-1, IEC 60601-2-57 standards for safety and the IEC 60601-1-2 standard for EMC.
Usability
Usability testing has been conducted, and the E>EYE C complies with IEC 60601-1-6.
Photobiological safety
Safety testing has been conducted, and the E>EYE C complies with IEC 62471.
Software Verification and Validation
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could not directly result in serious injury or death to the patient or operator.
Clinical Data
None.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K170060, K192539

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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June 11, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

E-swin Emeric OBIN Regulatory Affairs Manager Rue des Cotes D'orval, ZA de la prevote Houdan, Yvelines 78550 France

Re: K200616

Trade/Device Name: E>EyeC 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: ONF Dated: April 13, 2020 Received: April 13, 2020

Dear Emeric OBIN:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Colin Kejing Chen, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K200616

Device Name E>Eye C

Indications for Use (Describe)

The E>Eye is a prescription device intended for the treatment of rosacea

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

1) Applicant Name:

E-SWIN Rue des Côtes d'Orval, ZA de la Pévôté 78550 Houdan, France Tel: [phone] Fax: [phone]

2) Contact Person:

Emeric OBIN, Regulatory Affairs Manager Rue des Côtes d'Orval, ZA de la Pévôté 78550 Houdan, France Tel: [phone] Fax: [phone] Mail: [e-mail]

3) Date Prepared:

June 11, 2020

4. Trade Name: E>EYE C

5) Regulatory Information

Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Product Code: ONF Class: Class II Regulation Number: 21 CFR 878.4810

E-SWIN – SAS au capital de 195.000 euros - RCS Versailles 501 515 423 Rue des Côtes d'Orval, ZA de la Prévôté, 78550 Houdan- FRANCE tel : [phone]

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Panel: General & Plastic Surgery

Predicate Devices: Lumenis M22 System (K170060) , DEKA LUXEA LAZUR Pulsed Light Handpiece (K192539)

Indications for Use: The complete phrasing of the indications for use statement is provided in the formal Indications for Use Statement (FDA Form 3881).

6) Intended use:

The E>Eye is a prescription device intended for the treatment of rosacea.

7) Device Description:

The E>Eye C is an intense pulsed light system composed of a base housing the electric and electronics sub-assemblies, and a handheld piece "applicator" connected to the base by a cord. The applicator contains the source of optical radiation.

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8) Technological Characteristics and Substantial Equivalence:

The intended use and indications for use of the E>EYE C are the same as the selected predicate devices. In addition, the same technological characteristics and principles of operation apply for the E>EYE C and the predicate device.

	Predicate Device	Predicate Device	Device
Device Name	Lumenis M22 System IPL
Handpiece
(K170060)	DEKA LUXEA LAZUR
Pulsed Light handpiece
(K192539)	E>EYE C
Energy Medium	Flashlamp	Flashlamp	Flashlamp
Wavelength Range	400-1200nm	420-950nm	580-1200nm, cutoff
before 580nm
Pulse Duration	40-100ms - multiple
pulse	30, 40, 50 ms	170ms - multiple
pulse
Energy Density	10-56J/cm2	3-20J/cm2	8-13j/cm2
Spot size	6cm2	6.2cm2	7.5cm2
Intended Use	Benign cutaneous
vascular lesions,
including port wine
stains, hemangiomas,
facial, truncal and leg
telangiectasias, erythema
of rosacea, angiomas and
spider angiomas,
poikiloderma of Civatte,
leg veins and venous
malformations	- The treatment of
benign cutaneous
vascular lesions including
port wine stains,
hemangiomas, facial,
truncal and leg
telangiectasias, rosacea,
erythema of rosacea,
angiomas and spider
angiomas, poikiloderma
of Civatte, leg veins and
venous malformations.	Treatment of
rosacea

Minor differences can be found in spot size, wavelength and energy density. Those differences do not raise additional safety or effectiveness questions.

The E>EYE C has the same indications for use, same technology, comparable pulse duration as its predicates.

E-SWIN - SAS au capital de 195.000 euros - RCS Versailles 501 515 423 Rue des Côtes d'Orval, ZA de la Prévôté, 78550 Houdan- FRANCE tel : [phone]

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9) PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

NON-CLINICAL

Electrical safety and electromagnetic compatibility

(EMC) Electrical safety and EMC testing were conducted on the E>EYE C, composed of its base and its applicator/handpiece. The system complies with the IEC 60601-1, IEC 60601-2-57 standards for safety and the IEC 60601-1-2 standard for EMC.

Usability

Usability testing has been conducted, and the E>EYE C complies with IEC 60601-1-6.

Photobiological safety

Safety testing has been conducted, and the E>EYE C complies with IEC 62471.

Software Verification and Validation

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could not directly result in serious injury or death to the patient or operator.

Clinical Data

None.

10) Conclusions:

The E>EYE C was found to perform as well as its predicate, to be as safe and effective for its intended use as its predicate, and is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issues.

E-SWIN - SAS au capital de 195.000 euros - RCS Versailles 501 515 423 Rue des Côtes d'Orval, ZA de la Prévôté, 78550 Houdan- FRANCE tel : [phone]

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