(95 days)
Not Found
No
The document describes a standard IPL and laser system for dermatological treatments. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections.
Yes
The device is intended for the treatment of various medical conditions such as telangiectasias, rosacea, inflammatory acne vulgaris, port wine stains, benign vascular lesions, and onychomycosis, among others. These indications point to its use in actively treating diseases or conditions to restore health or alleviate symptoms.
No
The device description and intended use/indications for use specify that the Ellipse Nordlys system is used for various treatments in dermatology (e.g., hair reduction, treatment of telangiectasias, rosacea, acne, etc.). It describes therapeutic applications, not diagnostic ones.
No
The device description explicitly states that the system consists of a console containing a power unit, control electronics, and hand-pieces (IPL and Nd:YAG) which are hardware components used to generate light energy for treatment. While it includes software, it is not a software-only device.
Based on the provided information, the Ellipse Nordlys system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Ellipse Nordlys Function: The Ellipse Nordlys system uses Intense Pulsed Light (IPL) and Nd:YAG Laser directly on the patient's skin for therapeutic purposes (hair reduction, treatment of various skin conditions, etc.). It does not analyze samples taken from the body.
- Intended Use: The intended uses listed are all related to treating conditions on the skin surface or within the body using light and laser energy.
- Device Description: The description details a system that generates light and laser energy and applies it to the patient, not a system for analyzing biological samples.
Therefore, the Ellipse Nordlys system falls under the category of therapeutic medical devices, not In Vitro Diagnostic devices.
N/A
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 555-950mm).
· 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.
Product codes
GEX
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.
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)
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 3rd 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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:
•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.
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.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 11 | |
| 2970 Hoersholm, Denmark | |
| Tel: +45 4576 8808 | |
| Fax: + 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 9SYS7773 |
| Ellipse Infinity 9SYS7774 | |
| Ellipse Mjølner 9SYS7775 | |
| Ellipse Nordlys+ 9SYS7776 | |
| Ellipse 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/S | |
| Agern 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)). |
4
Description of Ellinse Nordlys:
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.
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.