•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 555-950nm).

· Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (ex Diffuse Redness) (530-750nm or 555-950nm).

· Treatment of Rosacea (530-750nm or 555-950mm).

· 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: Y AG 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.).

· Treatment of benign cutaneous lesions, such as warts.

•Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue), including
Matrixectomy.
Periungal and subungal warts
Plantar warts.

Device Description

Ellipse Nordlys is an Intense Pulsed Light (IPL) and Nd:YAG Laser system used for long-term removal of unwanted hair; for treatment of sun-damaged skin, including uneven pigmentation, age spots, large pores, 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 Nordlys for treatment of vascular lesions as stated below under Intended Use/Indications for Use.

AI/ML Overview

This document, a 510(k) Summary for the Ellipse Nordlys device, does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices already on the market. In a 510(k) submission, the FDA often receives evidence that a new device is as safe and effective as a legally marketed predicate device. This typically involves comparing technological characteristics, performance, and intended use.

Here's a breakdown of why the requested information is not present and what the document does provide:

Missing Information (and why it's missing in a 510(k) Summary like this):

A table of acceptance criteria and the reported device performance: This would be found in a more detailed clinical or performance study report, which is usually part of the full 510(k) submission but not typically summarized in this public-facing document. The 510(k) summary focuses on equivalence to existing devices rather than a direct, quantitative performance validation against novel acceptance criteria.
Sample sized used for the test set and the data provenance: Not mentioned. This would be part of a specific study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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. This device is a laser/IPL system, not an AI diagnostic tool that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
The sample size for the training set: Not applicable for a device that is not an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable for a device that is not an AI/ML algorithm.

What the document does provide regarding "performance standards" and "equivalence" (which is the closest it gets to your request):

The document explicitly states that the Ellipse Nordlys system has been tested according to and complies with a list of regulatory and safety standards. These standards implicitly set "acceptance criteria" for the device's fundamental safety and electrical performance.

Performance Standards (serving as implicit "acceptance criteria" for safety and basic function):

US FDA 21 CFR 1040.10 and 1040.11: For class IV Laser Products (This relates to laser product performance, safety, and labeling requirements).
IEC 60601-1 3rd edition, UL 60601-1 and CSA C22.2 No. 601.1: Medical electrical equipment - General requirements for basic safety and essential performance.
IEC 60601-2-57: Particular requirements for the basic safety and essential performance of laser devices for dermal and aesthetic applications.
IEC 60825-1 and IEC 60601-2-22: Safety of laser products and particular requirements for surgical, therapeutic and diagnostic laser equipment.
IEC 60601-1-2: Electromagnetic compatibility.
Complies with the European Medical Device Directive 93/42/EEC (Annex II): A broad directive for medical devices in Europe.
Manufactured under ISO 13485 Quality Management System certified by Presafe/DGM and QMI and also complies with the US FDA 21CFR Part 820: Demonstrates a robust quality management system in place.

The "study" or evidence provided to meet these criteria is the compliance with these standards. This means the manufacturer has conducted tests (e.g., electrical safety tests, electromagnetic compatibility tests, laser output parameter tests) and demonstrated that the device meets the specifications and safety requirements outlined in these standards. The specific results of these tests are not detailed in this summary but would be part of the full submission.

Substantial Equivalence Conclusion:

The core "study" mechanism here is the comparative analysis for substantial equivalence. The manufacturer concluded: "The Ellipse Nordlys system 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." This means they presented data (likely including design specifications, output parameters, and sometimes clinical literature for the predicate devices) to convince the FDA that the Nordlys performs comparably to the already approved predicate devices. They explicitly state, "Based on this analysis of the overall performance of the mentioned predicate devices Ellipse A/S believes that no significant differences exist. The Ellipse Nordlys system should not raise new issues of safety or effectiveness."

Summary

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Image /page/0/Picture/1 description: The image is the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, with flowing lines representing hair or ribbons.

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

July 7, 2015

Ellipse A/S Ole Kofod Quality Assurance and Regulatory Affairs Manager Agern Alle 11 DK-2970 Hoersholm Denmark

Re: K150907

Trade/Device Name: Ellipse Nordlys 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: GEX Dated: June 8, 2015 Received: June 17, 2015

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 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

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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 (OS) 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/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 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,

Jennifer R. Stevenson -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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Indications for Use

510(k) Number (if known) K150907

Device Name Ellipse Nordlys

Indications for Use (Describe)

Ellipse Nordlys system is intended to be used in dermatology, as tabled below:

·Treatment of Telangiectasias (530-750nm or 555-950mm).

· Treatment of Port Wine Stains (530-750nm or 555-950nm).

· Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (ex Diffuse Redness) (530-750nm or 555-950nm).

· Treatment of Rosacea (530-750nm or 555-950mm).

· 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: Y AG 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.).

· Treatment of benign cutaneous lesions, such as warts.

•Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue), including
Matrixectomy.
Periungal and subungal warts
Plantar warts.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary – Section 3

Ellipse Nordlys

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:	30 March 2015
Submitted by/manufacturer:	Ellipse A/S (Establishment Registration no. 3005112495)Agern Alle 112970 Hoersholm, DenmarkTel: +45 4576 8808Fax: + 45 4517 6851
Contact person:	Ole Kofod
Device Identification:
Device Trade Name 1:	Ellipse Nordlys (with IPL and Nd:YAG hand pieces/applicators).
Device Model number 1:	9SYS7751.
Alternative Device Trade Name and Model:	Ellipse Sirius 9SYS7773Ellipse Infinity 9SYS7774Ellipse Mjølner 9SYS7775Ellipse Nordlys+ 9SYS7776Ellipse Nordlys ultra 9SYS7777
Common Name:	Intense Pulsed Light (IPL) & Laser.
Classification name:	Laser surgical instrument for use in general and plastic surgery and in dermatology (per 21 CFR Part 878.4810).
Device classification:	Class II
Product code:	GEX
Predicate Devices:
Predicate devices legally marketed to which Ellipse A/S claims substantial equivalence:	Ellipse MultiFlex+ TM (K140670).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)).
	Genesisplus Laser System TM (K122493)Cutera, Inc., 3240 Bayshore Blvd., Brisbane, CA94005, USA.(Laser surgical instrument for use in general and plastic surgery and in dermatology (per 21 CFR Part 878.4810)).
	Candela V-beam TM (K033461)Candela Corporation, 530 Boston Post Rd., Wayland, MA01778, USA.(Laser surgical instrument for use in general and plastic surgery and in dermatology (per 21 CFR Part 878.4810)).

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Description of Ellinse Nordlys:

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 Nordlys for treatment of vascular lesions as stated below under Intended Use/Indications for Use.

Intended Use/Indications for Use:

Ellipse Nordlys system is 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 555-950nm).
Treatment of Port Wine Stains (530-750nm or 555-950nm). ●
Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (eg Diffise ● 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).
. 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.).
. Treatment of benign cutaneous lesions, such as warts.
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue), including ●
- Matrixectomy.
- Periungal and subungal warts
- Plantar warts.

Performance Standards

The Ellipse Nordlys Intense Pulsed Light (IPL) and Laser system has 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 Nordlys system 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 Nordlys has been evaluated and compared to the above mentioned predicate systems and to their application modules. The Ellipse Nordlys 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 Nordlys system 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.