Permanent hair reduction (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) (overall 600-950nm).
Treatment of Telangiectasias (530-750nm or 555-950nm).
Treatment of Port Wine Stains (530-750nm or 555-950nm).
Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (eg Diffüse Redness) (530-750nm or 555-950nm).
Treatment of Rosacea (530-750nm or 555-950nm).
Treatment of Poikiloderma of Civatte (530-750nm or 555-950nm).
Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris) (400-720nm).
Treatment of Inflammatory Acne vulgaris (530-750mm).

Using Nd: YAG laser. (1064nm) (Ellipse MultiFlex+ system, only):

Treatment of Leg vessels (0.1 -3.0mm diameter).
Treatment of Benign Vascular Lesions.
Treatment of Venous Lakes.
Treatment of Port Wine Stains.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Device Description

Ellipse PPL+ and Ellipse Multiflex+ are identical Intense Pulsed Light (IPL) systems used for long-term removal of unwanted hair; for treatment of sun-damaged skin, including uneven pigmentation, are spots, diffuse redness, and for the treatment of telangiectasias, port wine stains, rosacea, poikiloderma of civatte and inflammatory acne in the area of dermatology.

The systems consist of a console containing power unit and control electronics with control and display panel including software.

IPL Applicators/hand-pieces are connected to the systems in order to generate light energy for treatment in the waveband 400 nm - 950 nm.

Additionally a Nd: YAG handpiece (1064 nm) can be connected to the Ellipse MultiFlex+ for treatment of vascular lesions as stated below under Intended Use/Indications for Use.

AI/ML Overview

The document does not provide details of a study that proves the device meets specific acceptance criteria in the format typically used for medical device performance evaluation. This document is a 510(k) summary for the Ellipse I2PL+ and Ellipse MultiFlex+ systems, primarily focused on establishing substantial equivalence to predicate devices rather than presenting detailed performance study results against predefined acceptance criteria.

However, based on the provided text, we can glean some information about performance standards applied to the device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance standards that the device complies with, which can be seen as "acceptance criteria" in a regulatory compliance sense, although it doesn't present a table with specific numerical performance metrics and their corresponding acceptance thresholds.

Acceptance Criteria (Compliance Standard)	Reported Device Performance (Compliance Statement)
US FDA 21 CFR 1040.10 and 1040.11 (for class IV Laser Products)	Complies
IEC 60601-1 3rd edition	Complies
UL 60601-1	Complies
CSA C22.2 No. 601.1	Complies
IEC 60601-2-57	Complies
IEC 60825-1	Complies
IEC 60601-2-22	Complies
IEC 60601-1-2	Complies
European Medical Device Directive 93/42/EEC (Annex II)	Complies
US FDA 21CFR Part 820 (Quality System Regulation)	Complies (Manufactured under ISO13485 QMS certified by Presafe/DGM and QMI, and also complies with US FDA 21CFR Part 820)

2. Sample size used for the test set and the data provenance:

The document does not mention any specific sample sizes for a clinical test set or details about data provenance (e.g., country of origin, retrospective/prospective). The performance evaluation appears to be based on compliance with harmonized standards and comparison to predicate devices, rather than a clinical study with a dedicated test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The regulatory submission emphasizes substantial equivalence and compliance with technical standards, not detailed clinical trial results involving ground truth established by experts.

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

This information is not provided.

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:

This type of study is not mentioned. The device described is an Intense Pulsed Light (IPL) and Laser system, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable as the device is a therapeutic energy-based system, not an algorithm. Its "standalone" performance would relate to its physical and energetic output specifications, which are presumably covered by the referenced compliance standards.

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

Not explicitly defined in the context of clinical performance data. The "ground truth" implicitly refers to the device's ability to consistently meet the technical specifications and safety requirements outlined in the cited standards. For the "Indications for Use" (e.g., permanent hair reduction, treatment of telangiectasias), the effectiveness would be determined by clinical outcomes, but no specific outcome data or how it was established is provided in this summary. The definition of "Permanent hair reduction" does indicate measurement at "6, 9, and 12 months after the completion of a treatment regime," implying clinical follow-up for that specific indication, but details of such a study are absent.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device.

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

September 25, 2014

Ellipse A/S Mr. Ole Kofod Quality Assurance/Regulatory Affairs Manager Agern Allé 11 DK-2970 Hoersholm Denmark

Re: K140670

Trade/Device Name: Ellipse I2PL+ (with IPL hand pieces/applicators), Ellipse MultiFlex+(with IPL and Nd:YAG hand pieces/applicators) 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, GEX Dated: September 5, 2014 Received: September 11, 2014

Dear Mr. Kofod:

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

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

David Krause -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140670

Device Name Ellipse I2PL+ Ellipse MultiFlex+

Indications for Use (Describe)

Ellipse I2PL+ and Ellipse MultiFlex+ systems are intended to be used in dermatology, as tabled below:

Permanent hair reduction (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) (overall 600-950nm).
Treatment of Telangiectasias (530-750nm or 555-950nm).
Treatment of Port Wine Stains (530-750nm or 555-950nm).
Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (eg Diffüse Redness) (530-750nm or 555-950nm).
Treatment of Rosacea (530-750nm or 555-950nm).
Treatment of Poikiloderma of Civatte (530-750nm or 555-950nm).
Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris) (400-720nm).
Treatment of Inflammatory Acne vulgaris (530-750mm).

Using Nd: YAG laser. (1064nm) (Ellipse MultiFlex+ system, only):

Treatment of Leg vessels (0.1 -3.0mm diameter).
Treatment of Benign Vascular Lesions.
Treatment of Venous Lakes.
Treatment of Port Wine Stains.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FDA USE ONLY CONLY CONTRACT THE

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Summary – Section 3 Rev 3

Ellipse I²PL+ Ellipse MultiFlex+

This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.87(h) and Part 807.92.

Submitter Information:

Date of the summary:	28 August 2014
Submitted by/manufacturer:	Ellipse A/S (Establishment Registration no. 3005112495)
	Agern Alle 11
	2970 Hoersholm, Denmark
	Tel: + 45 4576 8808
Contact person:	Ole Kofod
	Fax: + 45 4517 6851

Device Identification:

Device Trade Name 1:	Ellipse I²PL+ (with IPL hand pieces/applicators).
Device Model number 1:	9ESL7228.
Device Trade Name 2:	Ellipse MultiFlex+ (with IPL and Nd:YAG hand pieces/applicators).
Device Model number 2:	9ESF7496.
Common Name:	Intense Pulsed Light (IPL) & Laser.
Classification name:	Laser surgical instrument for use in general and plastic surgery and indermatology (per 21 CFR Part 878.4810).
Device classification:	Class II (per 21 CFR 870.1250).
Product code:	GEX

Predicate Devices:

Predicate devices legally marketedto which Ellipse A/S claimssubstantial equivalence:	Ellipse I2PL (K060516).Ellipse A/SAgern Alle 11, DK-2970 Hoersholm, Denmark.(Laser surgical instrument for use in general and plastic surgery and in dermatology(per 21 CFR Part 878.4810)).
	Ellipse MultiFlex (K081408).Ellipse A/SAgern Alle 11, DK-2970 Hoersholm, Denmark.(Laser surgical instrument for use in general and plastic surgery and in dermatology(per 21 CFR Part 878.4810)).
	StarLuxTM Pulsed Light System (K041086).
	Palomar Medical Technologies, Inc., 82 Cambridge Street, Burlington, MA 01803,USA.
	(Laser surgical instrument for use in general and plastic surgery and in dermatology(per 21 CFR Part 878.4810)).
	IconTM
	Palomar Medical Technologies, Inc., 82 Cambridge Street, Burlington, MA 01803,USA.
	(Laser surgical instrument for use in general and plastic surgery and in dermatology(per 21 CFR Part 878.4810)).
	Genesisplus Laser SystemTM
	Cutere, Inc., 3240 Bayshore Blvd., Brisbane, CA94005, USA.

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Description of Ellipse I2PL+ and Ellipse MultiFlex+:

The systems consist of a console containing power unit and control electronics with control and display panel including software.

IPL Applicators/hand-pieces are connected to the systems in order to generate light energy for treatment in the waveband 400 nm - 950 nm.

Additionally a Nd: YAG handpiece (1064 nm) can be connected to the Ellipse MultiFlex+ for treatment of vascular lesions as stated below under Intended Use/Indications for Use.

Intended Use/Indications for Use:

Ellipse I2PL+ and Ellipse MultiFlex+ systems are intended to be used in dermatology, as tabled below:

Permanent Hair Reduction (defined as the long-term, stable reduction in the number of hairs re-growing when measured ● at 6, 9, and 12 months after the completion of a treatment regime) (overall 600-950nm).
. Treatment of Telangiectasias (530-750nm or 555-950mm).
Treatment of Port Wine Stains (530-750nm or 555-950mm). ●
Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (eg Diffuse ● Redness) (530-750nm or 555-950nm).
Treatment of Rosacea (530-750nm or 555-950nm).
Treatment of Poikiloderma of Civatte (530-750nm or 555-950nm). ●
. Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris) (400-720nm).
Treatment of Inflammatory Acne Vulgaris (530-750nm). ●
o Using Nd: YAG laser, (1064nm) (Ellipse MultiFlex+ system, only):
Treatment of Leg vessels (0.1 -3.0mm diameter). ●
Treatment of Benign Vascular Lesions .
Treatment of Venous Lakes .
Treatment of Port Wine Stains
Treatment for Clear Nail defined as: Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Performance Standards

The Ellipse I PL+ and Ellipse MultiFlex+ Intense Pulsed Light (IPL) and Laser systems have been tested according to and comply with:

· US FDA 21 CFR 1040.10 and 1040.11 for class IV Laser Products.
IEC 60601-1 3td edition, UL 60601-1 and CSA C22.2 No. 601.1. .
· IEC 60601-2-57.
IEC 60825-1 and IEC 60601-2-22. .
IEC 60601-1-2. .
Complies with the European Medical Device Directive 93/42/EEC (Annex II). ●
Manufactured under ISO13485 Quality Management System certified by Presafe/DGM and QMI and also complies with ● the US FDA 21CFR Part 820.

Substantial Equivalence conclusion:

The Ellipse I PL+ and Ellipse MultiFlex+ systems are substantially equivalent in terms of technological characteristics, performance, intended use/indications for use to the predicate devices listed on page 1 of this document.

The Ellipse I PL+ and Ellipse MultiFlex+ has been evaluated and compared to the above mentioned predicate systems and to their application modules. The Ellipse MultiFlex+ as far as far as the identical modules, applications, parameters, and intended uses/indications are concerned, have been judged to be substantially equivalent to the mentioned predicate devices. Based on this analysis of the overall performance of the mentioned predicate devices Ellipse A/S believes that no significant differences exist. The Ellipse MultiFlex+ systems should not raise new issues of safety or effectiveness.

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.