(164 days)
The ePlus Skin Treatment system is intended for dermatological procedures.
The DS applicator is indicated for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction*.
The DSL applicator is indicated for hair removal, permanent hair reduction*. The applicator is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.
The LV applicator is indicated for treatment of vascular lesions.
The LVA applicator is indicated for treatment of vascular lesions.
The WRA applicator is indicated for non invasive wrinkles treatment.
The SR applicator is intended for superficial benign vascular and pigmented lesion treatment such as:
lentigines, freckles, telangiectasia, rosacea, poikiloderma, angioma, sun spots and age spots.
The SR treatment may be performed on body areas such as the face, chest, hands and arms. It can be also performed on sporadic lesions anywhere on the body.
The SRA applicator is intended for superficial benign vascular and pigmented lesion treatment such as:
lentigines. freckles, telangiectasia, rosacea, poikiloderma. angioma, sun spots and age spots.
The SRA treatment may be performed on body areas such as the face, chest, hands and arms. It can be also performed on sporadic lesions anywhere on the body.
The AC applicator is indicated for the treatment of moderate inflammatory acne vulgaries.
The Sublative RF applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles.
The Sublime applicator is indicated for non invasive wrinkles treatment.
- Permanent hair reduction is 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 regimen
The ePlus skin treatment system is a multi-application system that provides a variety of skin treatments. The system combines Syneron's previously cleared Polaris, Aurora and eTwo treatment Systems and their applicators. The ePlus skin treatment system delivers two ranges of electromagnetic energy to the skin tissue through the system applicators:
- Optical radiation through Laser or IPL (Intense Pulse Light) in the visible & near-IR range.
- RF current conducted through the tissue at 1MHz
The provided document is a 510(k) summary for the Syneron ePlus Skin Treatment System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting new clinical studies with detailed acceptance criteria and performance data. Therefore, many of the requested details about specific study design elements (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not explicitly present in the document because they were not required for this type of submission.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for the ePlus Skin Treatment System itself. Instead, the "acceptance criteria" for the 510(k) clearance process were met through demonstrating substantial equivalence to previously cleared predicate devices and compliance with safety standards.
-
Acceptance Criteria (Implicit for 510(k) Clearance):
- Substantial equivalence to predicate devices in intended use and technical performance.
- Compliance with recognized safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2 Ed. 2.1).
-
Reported Device Performance:
The document states: "The safety and efficacy of the ePlus Skin Treatment System was evaluated in the clearance process of the predicate devices that use the same applicators that are part of this device. Syneron believes that clinical data is not required to determine the safety and efficacy of the ePlus Skin Treatment System since the intended use and technical performance of ePlus and its applicators are equivalent to the predicate devices."Therefore, the reported performance is implied to be equivalent to that of the predicate devices listed for each applicator, which had already demonstrated safety and effectiveness for their respective indications. The specific performance metrics (e.g., hair reduction percentages, lesion clearance rates) for the predicate devices are not detailed in this 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Syneron believes that clinical data is not required to determine the safety and efficacy of the ePlus Skin Treatment System since the intended use and technical performance of ePlus and its applicators are equivalent to the predicate devices."
This indicates that no new clinical test set was used for the ePlus Skin Treatment System itself to demonstrate its safety and efficacy for this 510(k) submission. The safety and efficacy data were derived from the clearance processes of the predicate devices. Therefore, details like sample size, data provenance (country, retrospective/prospective), and ground truth establishment for a new test set are not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no new test set was used for the ePlus Skin Treatment System in this 510(k) process. The effectiveness and safety were supported by data from the predicate devices.
4. Adjudication Method for the Test Set
Not applicable, as no new test set was used for the ePlus Skin Treatment System in this 510(k) process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
Not applicable. The ePlus Skin Treatment System is a medical device for dermatological procedures (laser/IPL and RF energy delivery), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an energy delivery system used by a human operator, not an algorithm, and thus does not have "standalone" algorithmic performance in the context of AI or diagnostic systems.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the predicate devices' original clinical studies (which supported their initial clearance and thus implicitly support this 510(k)) would have varied depending on the indication:
- Hair Reduction: Likely involved objective measurements of hair count reduction over time (e.g., 6, 9, 12 months post-treatment) and potentially photographic assessment, possibly with expert review.
- Vascular/Pigmented Lesions: Likely involved clinical assessment by dermatologists/physicians, potentially photographic documentation, and
- For benign pigmented lesions, visual assessment by experts might be sufficient.
- For vascular lesions, visual assessment and potentially quantitative measures (e.g., lesion area reduction) or subjective improvement scores.
- Wrinkle Treatment: Typically involves objective measures like wrinkle severity scales (e.g., Glogau scale) or optical profilometry, along with subjective patient satisfaction and physician assessment.
- Acne Treatment: Typically involves counting inflammatory and non-inflammatory lesions (comedones, papules, pustules, nodules) and assessing global severity scores.
- Ablation and Resurfacing: Involves clinical assessment of skin texture, resurfacing depth, and healing, potentially with histological examination.
However, these details are not provided within this 510(k) document for the ePlus system, as it relies on previous clearances.
8. The Sample Size for the Training Set
Not applicable. As noted, no new clinical studies were conducted for the ePlus system as presented in this 510(k). The system itself is an energy delivery device, not a machine learning model requiring a training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
In summary: The Syneron ePlus Skin Treatment System obtained 510(k) clearance by demonstrating substantial equivalence to previously cleared predicate devices whose safety and efficacy had already been established through their own respective clearance processes. Therefore, this 510(k) summary does not include new clinical study data with specific acceptance criteria, sample sizes, expert qualifications, or detailed ground truth establishment methods for the ePlus system itself. Instead, it references the prior clearances and compliance with general safety standards.
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510(K) SUMMARY
ePlus Skin Treatment System 510(k) Number K113868
| Applicant's Name: | Syneron Medical Ltd. |
|---|---|
| Industrial Zone | |
| Tavor Building | |
| Yokneam Illit 20692 | |
| Israel | |
| Tel: (972)73-244-2200 | |
| Fax: (972)73-244-2202 | |
- Yoram Levy, Osite Contact Person: 31 Haavoda Street Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com
Trade Name:
ePlus Skin Treatment System
December 27. 2011 Preparation Date:
Name: Powered laser surgical instrument Classification: Product Code: GEX, OUH Regulation No: 21 CFR 878.4400, 21CFR 878.4810 Class: II Panel: General and Plastic Surgery
Device Description:
The ePlus skin treatment system is a multi-application system that provides a variety of skin treatments. The system combines Syneron's previously cleared Polaris, Aurora and eTwo treatment Systems and their applicators. The ePlus skin treatment system delivers two ranges of electromagnetic energy to the skin tissue through the system applicators:
- Optical radiation through Laser or IPL (Intense Pulse Light) in 1. the visible & near-IR range.
- RF current conducted through the tissue at 1MHz
Intended Use Statement:
The ePlus Skin Treatment system is intended for dermatological procedures.
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113868 2/3
Medical LTD
meron
The DS applicator is indicated for the removal of unwanted hair from skin types I-VI. and to effect stable long-term, or permanent, hair reduction*.
The DSL applicator is indicated for hair removal, permanent hair reduction*. The applicator is intended for use on all skin types. (Fitzpatrick skin type I-VI), including tanned skin.
The LV applicator is indicated for treatment of vascular lesions.
The LVA applicator is indicated for treatment of vascular lesions.
The WRA applicator is indicated for non invasive wrinkles treatment.
The SR applicator is intended for superficial benign vascular and pigmented lesion treatment such as:
lentigines. freckles. telangiectasia. rosacea. poikiloderma, angioma, sun spots and age spots.
The SR treatment may be performed on body areas such as the face. chest. hands and arms. It can be also performed on sporadic lesions anywhere on the body.
The SRA applicator is intended for superficial benign vascular and pigmented lesion treatment such as:
lentigines. freckles. telangiectasia. rosacea. poikiloderma. angioma, sun spots and age spots.
The SRA treatment may be performed on body areas such as the face, chest, hands and arms. It can be also performed on sporadic lesions anywhere on the body.
The AC applicator is indicated for the treatment of moderate inflammatory acne vulgaries.
The Sublative RF applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles.
The Sublime applicator is indicated for non invasive wrinkles treatment.
- Permanent hair reduction is 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 regimen
Substantial equivalence to the following predicate devices is Predicate Devices: claimed:
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Image /page/2/Picture/0 description: The image contains the word "Syneron" in a stylized font. The word is written in black ink and appears to be part of a logo or brand name. Below the word "Syneron" is the word "Medical LTD".
113 867. 7/3
Medical LTD
| Syneron Device Name | 510k No | Date of Clearance |
|---|---|---|
| Polaris DS / Comet Applicator | K041959 | November 8, 2004 |
| Polaris LV | K030186 | April 14, 2003 |
| Polaris WR | K031671 | December 1, 2003 |
| Aurora SR | K031993 | August 1, 2003 |
| AC applicator, Aurora AC | K032514 | January 27, 2004 |
| Aurora DS, DS applicator | K050796 | April 12, 2005 |
| Aurora SR and SRA applicator | K050452 | March 9, 2005 |
| Polaris LV, LVA applicator | K052324 | September 14, 2005 |
| eTwo Skin Treatment System | K110672 | October 03, 2011 |
Performance Standards:
ePlus Skin Treatment System complies with:
- . IEC 60601-1 : "Medical Electrical Equipment" Part 1: "General requirements for safety"
- IEC 60601-2-2: "Medical Electrical Equipment" Part 2: "Particular . requirements for the safety of high frequency surgical equipment" (2006)
- IEC 60601-2-22 : "Medical Electrical Equipment" Part 2: . ● "Particular requirements for the safety of diagnostic and therapeutic laser equipment" (1995)
- IEC60825-1 : Safety of laser products Part 1: "Equipment . classification, requirements and user's guide" (2007)
- IEC 60601-1-2 Ed. 2.1 (2004): medical electrical equipment: Part . 1-2 collateral standard: Electromagnetic compatibility Requirements and tests"
A detailed description appears in Section 13.
Summary of Clinical Performance Data:
The safety and efficacy of the ePlus Skin Treatment System was evaluated in the clearance process of the predicate devices that use the same applicators that are part of this device. Syneron believes that clinical data is not required to determine the safety and efficacy of the ePlus Skin Treatment System since the intended use and technical performance of ePlus and its applicators are equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 1 2012
- Syneron. Ltd Yo Osite Yoram Levy 31 Haavoda Street Binyamina, Israel 30500
Re: K113868
Trade/Device Name: ePlus Skin Treatment System 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 01, 2012 Received: June 05, 2012
Dear Yoram Levy:
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.
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Page 2 - Yoram Levy
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Mark Millikan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ineron Medical LTD
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K113868
Device Name:
ePlus Skin Treatment System
Indications for Use:
The ePlus Skin Treatment system is intended for dermatological procedures.
The DS applicator is indicated for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction*.
The DSL applicator is indicated for hair removal. permanent hair reduction*. The applicator is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.
The LV applicator is indicated for treatment of vascular lesions.
The LVA applicator is indicated for treatment of vascular lesions.
The WRA applicator is indicated for non invasive wrinkles treatment.
The SR applicator is intended for superficial benign vascular and pigmented lesion treatment such as:
lentigines, freckles, telangiectasia, rosacea, poikiloderma, angioma, sun spots and age spots.
The SR treatment may be performed on body areas such as the face, chest, hands and arms. It can be also performed on sporadic lesions anywhere on the body.
The SRA applicator is intended for superficial benign vascular and pigmented lesion treatment such as:
lentigines. freckles, telangiectasia, rosacea, poikiloderma, angioma, sun spots and age spots.
The SRA treatment may be performed on body areas such as the face, chest, hands and arms. It can be also performed on sporadic lesions anywhere on the body.
The AC applicator is indicated for the treatment of moderate inflammatory acne vulgaries.
ePlus Skin Treatment System - 510(k) Notification
Neil RPDoplin for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113868
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Image /page/6/Picture/0 description: The image shows the logo for Syneron Medical LTD. The word "Syneron" is written in a stylized font, with the "S" having a unique design. Below "Syneron" is the text "Medical LTD" in a standard, bold font. The logo appears to be for a medical company.
The Sublative RF applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles.
The Sublime applicator is indicated for non invasive wrinkles treatment.
*Permanent hair reduction is 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 regimen
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off), Division of General, Restorative and Neurological Devices 510(k) Number
Neihroplen Sir mxm
(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113868
§ 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.