(191 days)
Not Found
No
The document describes a standard IPL and laser system with control electronics and software, but there is no mention of AI or ML capabilities, image processing for analysis, or any details about training or test data sets which are typical for AI/ML devices.
Yes
The device is intended for the treatment of various medical conditions such as telangiectasias, rosacea, inflammatory acne vulgaris, port wine stains, and benign vascular/pigmented lesions, which are all therapeutic interventions.
No
The device description and intended use clearly state that the Ellipse I2PL+ and Ellipse MultiFlex+ systems are used for various dermatological treatments, such as hair reduction, treatment of telangiectasias, port wine stains, benign pigmented and vascular lesions, rosacea, poikiloderma of Civatte, inflammatory acne, leg vessels, venous lakes, and onychomycosis. There is no mention of the device being used for diagnosis or identifying a condition.
No
The device description explicitly states that the systems consist of a console containing a power unit, control electronics, and hand-pieces (IPL Applicators and Nd: YAG handpiece) which are hardware components used to generate light energy for treatment. While the console includes software, the device is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The Ellipse I2PL+ and Ellipse MultiFlex+ systems use Intense Pulsed Light (IPL) and Nd: YAG laser to treat various dermatological conditions and for hair reduction. They directly interact with the patient's body (skin, hair, nails) using light energy.
- Lack of Specimen Examination: The description does not mention the examination of any biological specimens outside of the body. The treatment is applied directly to the patient.
Therefore, the device's intended use and mechanism of action clearly place it outside the scope of In Vitro Diagnostics. It is a therapeutic device used for direct treatment of patients.
N/A
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 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 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 (530-750mm).
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.).
Product codes (comma separated list FDA assigned to the subject device)
ONF, GEX
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.
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)
Not Found
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.
Ellipse I2PL (K060516), Ellipse MultiFlex (K081408), StarLuxTM Pulsed Light System (K041086)
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.
0
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
1
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
2
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)
3
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."
4
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 in |
| dermatology (per 21 CFR Part 878.4810). | |
| Device classification: | Class II (per 21 CFR 870.1250). |
| Product code: | GEX |
Predicate Devices:
| Predicate devices legally marketed
to which Ellipse A/S claims
substantial equivalence: | Ellipse I2PL (K060516).
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)). |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ellipse MultiFlex (K081408).
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)). |
| | 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. |
5
Description of Ellipse I2PL+ and Ellipse MultiFlex+:
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.
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.