(144 days)
Not Found
No
The summary describes a light and laser system for dermatological treatments and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes.
The device is intended to treat various medical conditions and physiological processes, such as benign pigmented and vascular lesions, inflammatory acne, warts, and onychomycosis, which are considered therapeutic applications.
No
Explanation: The device is described as an Intense Pulsed Light (IPL) and Laser system used for various dermatological treatments, such as hair reduction, treatment of skin conditions (telangiectasias, rosacea, acne, etc.), and skin resurfacing. Its intended use is therapeutic, not diagnostic.
No
The device description explicitly states it is an Intense Pulsed Light (IPL) and Laser system consisting of a console, power unit, control electronics, and hand-pieces/applicators, which are hardware components.
Based on the provided information, the Ellipse Nordlys system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Intended Use / Indications for Use and Device Description clearly state that the Ellipse Nordlys system is a light and laser system used for treating various dermatological conditions and for hair reduction. It directly interacts with the patient's skin and tissues.
Therefore, the Ellipse Nordlys system is a therapeutic device, not an in vitro diagnostic device.
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 555-950mm).
- · Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris) (400-720nm).
- · Treatment of Inflammatory Acne Vulgaris (530-750mm).
Using Nd:YAG Laser, (1064 nm):
- · Treatment of Leg vessels (0.1 -3.0 mm 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.
Using Frax 1550 Laser, (1550 nm):
· The Frax 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Ellipse Nordlys is an Intense Pulsed Light (IPL) and Laser system (Nd:YAG 1064 nm and Fractional 1550 nm) 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:Y AG hand piece (1064 nm) and a Fractional (1550 mm) hand piece can be connected to the Ellipse Nordlys for treatment of: Vascular lesions as stated below under Intended Use/Indications for Use for the Nd: YAG and fractional treatments for non-ablative skin resurfacing for Frax 1550 as stated below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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)
Testing certificates by UL International and Delta according to above listed Performance Standards were provided which demonstrates that Ellipse Nordlys with the listed applicators/handpieces utilize technical parameters which are as safe and effective as the predicate devices.
The default start settings for the Frax 1550 are based on the most relevant clinical investigations found to be safe and effective in the Ellipse literature study (RA18704, appendix 2) and equivalent to what are used as standard settings for the same treatments for Frax SR1550 (K130193) and Icon Lux1540 (K142376).
It is hereby proven that the chosen default parameters for Ellipse Frax1550 both are equivalent to settings already shown to be safe an effective by FDA cleared equipment (predicate devices) as well as being inside the mentioned consensus parameter recommendations. Furthermore, it is proven that the possible maximum energy settings for the individual treatments are inside what have already been considered to be safe and effective.
The new, added fractional application, Non-ablative Skin Resurfacing, is found to be substantially equivalent to the same application of the mentioned predicate devices.
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.
K150907, K142376, K130193, K080932, K130028
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
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with three human profiles incorporated into its design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2016
Ellipse A/S Ole Kofod QA/RA Manager Agern Alle 11 Hoersholm, DK-2970 DK
Re: K161162
Trade/Device Name: Frax 1550 For Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra 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: August 15, 2016 Received: August 18, 2016
Dear Ole 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
1
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 devicerelated adverse events) (21 CFR Part 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 Parts 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" (21 CFR 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,
Christopher J. Ronk -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) K161162
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 555-950nm).
- · Treatment of Poikiloderma of Civatte (530-750nm or 555-950mm).
- · Treatment of Benign Epidermal Pigmented Lesions (eg Lentigo Solaris) (400-720nm).
- · Treatment of Inflammatory Acne Vulgaris (530-750mm).
Using Nd:YAG Laser, (1064 nm):
- · Treatment of Leg vessels (0.1 -3.0 mm 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.
Using Frax 1550 Laser, (1550 nm):
· The Frax 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
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 - K161162
Ellipse Frax 1550 for 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: 13 September 2016
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:
Device Model number 1:
Alternative Device Trade Name and Model:
Common Name: Classification name:
Device classification: Product code:
Predicate Devices:
Predicate devices (for other than Frax 1550) legally marketed to which Ellipse A/S claims substantial equivalence:
Predicate devices (for Frax 1550) legally marketed to which Ellipse A/S claims substantial equivalence:
Frax 1550 for Ellipse Nordlys (with IPL and Nd: YAG hand pieces/applicators). 9APP7829 for 9SYS7751.
Ellipse Sirius system 9SYS7773 Ellipse Infinity system 9SYS7774 Ellipse Mjølner system 9S YS7775 Ellipse Nordlys+ system 9SYS7776 Ellipse Nordlys ultra system 9SYS7777
Intense Pulsed Light (IPL) & Laser. Laser surgical instrument for use in general and plastic surgery and in dermatology (per 21 CFR Part 878.4810). Class II (per 21 CFR 870.1250). GEX
Ellipse Nordlys (K150907) Ellipse A/S Agern Alle 11 DK-2970-Hørsholm, Denmark
Palomar Icon Aesthetic System (K142376) Cynosure Inc. 5 Carlisle Road Westford, MA 01886, USA
Fraxel Dual (K130193) Solta medical, Inc. 25881 Industrial Blvd. Hayward, CA 94545, USA
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Lutronic Mosaic (K080932) Lutronic Coorporation #403-2,3,4, Ilsan Technotown 1141-1Baeksok-Dong, Ilsan-Gu Goyang-Si, Gyeonggi-Do, 410-722 Republic of Korea
Lumenis ResurFX (K130028) Lumenis Ltd. 31 Haavoda St. Binyamina, IL 30500, USA
Description of Ellipse Nordlys with associated applicators (hand pieces):
Ellipse Nordlys is an Intense Pulsed Light (IPL) and Laser system (Nd:YAG 1064 nm and Fractional 1550 nm) 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:Y AG hand piece (1064 nm) and a Fractional (1550 mm) hand piece can be connected to the Ellipse Nordlys for treatment of: Vascular lesions as stated below under Intended Use/Indications for Use for the Nd: YAG and fractional treatments for non-ablative skin resurfacing for Frax 1550 as stated below.
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).
- 0 Treatment of Port Wine Stains (530-750nm or 555-950mm).
- Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions 0 (eg Diffuse Redness) (530-750nm or 555-950nm).
- 0 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, (1064 nm):
- Treatment of Leg vessels (0.1 -3.0mm diameter).
- . Treatment of Benign Vascular Lesions.
- @ Treatment of Venous Lakes.
- 0 Treatment of Port Wine Stains.
- Treatment for Clear Nail defined as: Temporary increase of clear nail in patients with onychomycosis (e.g., 0 dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
- 0 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.
Using Frax 1550 Laser, (1550 nm):
- The Frax 1550 nm Laser is indicated for use in dermatological procedures requiring the coagulation of soft 0 tissue, as well as for skin resurfacing procedures.
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Performance Standards utilized
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. .
- 0 Complies with the European Medical Device Directive 93/42/EEC (Annex II).
- 0 Manufactured under ISO13485 Quality Management System certified by Presafe/DGM and QMI and also complies with the US FDA 21CFR Part 820.
Performance Data
Testing certificates by UL International and Delta according to above listed Performance Standards were provided which demonstrates that Ellipse Nordlys with the listed applicators/handpieces utilize technical parameters which are as safe and effective as the predicate devices.
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Substantial Equivalence conclusion:
The Ellipse Nordlys system as regards its IPL and Nd: Y AG applications is identical to the previously cleared Ellinse Nordlys system (K150907).
An Ellipse Frax 1550 hand piece has now been added to the system (included in this application K16162). The Ellipse Frax 1550 hand piece has been evaluated and compared to the 1550mm hand piece of the predicate systems Cynosure/Palomar Icon® 1540 mm (K142376), Fraxel Dual® 1550 nm hand piece (K130193), Lumenis ResurFX (K130028) and Lutronic Mosaic (K080932).
Ellipse Frox 1550 is found to be substantial equivalent to these with respect to clinical and biological issues of these systems.
The default start settings for the Frax 1550 are based on the most relevant clinical investigations found to be safe and effective in the Ellipse literature study (RA18704, appendix 2) and equivalent to what are used as standard settings for the same treatments for Frax SR1550 (K130193) and Icon Lux1540 (K142376).
It is hereby proven that the chosen default parameters for Ellipse Frax1550 both are equivalent to settings already shown to be safe an effective by FDA cleared equipment (predicate devices) as well as being inside the mentioned consensus parameter recommendations. Furthermore, it is proven that the possible maximum energy settings for the individual treatments are inside what have already been considered to be safe and effective.
The new, added fractional application, Non-ablative Skin Resurfacing, is found to be substantially equivalent to the same application of the mentioned predicate devices.
Based on this analysis of the overall performance characteristics of the mentioned predicate devices Ellipse A/S believes that no significant differences exist. The Ellinse Nordlys system, now with the Ellipse Frax 1550 Laser applicator/hand piece added, should not raise new issues of safety and effectiveness and are judged to be substantially equivalent to the mentioned predicate devices.
Dee Roford
(Signature)
Ole Kofod (Typed Name)
13-September-2016 (Date)
K161162 (Premarket Notification 510(K) number).