(208 days)
Not Found
No
The document describes a system using RF and infrared light for skin treatment, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as a "Skin Treatment System" used for "dermatological procedures," "ablation and resurfacing of the skin," and "treatment of facial wrinkles," all of which are interventions aimed at improving a health condition or modifying body function, thus classifying it as therapeutic.
No
The device is described as a "Skin Treatment System" performing "dermatological procedures" like "ablation and resurfacing of the skin" and "wrinkles treatment," which are therapeutic applications, not diagnostic ones.
No
The device description explicitly states it is a "mobile operating system combining two treatment applicators," which are physical hardware components used for delivering energy to the skin.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dermatological procedures" and "treatment of facial wrinkles." These are procedures performed directly on the patient's skin.
- Device Description: The description details applicators that deliver energy (RF and infrared light) to the skin for remodeling, resurfacing, and tightening. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The eTwo Skin Treatment system is intended for dermatological procedures.
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."
Product codes (comma separated list FDA assigned to the subject device)
GEI, OUH
Device Description
The eTwo skin treatment system is a mobile operating system combining two treatment applicators:
- . Sublative RF applicator, which is intended for dermatological procedures requiring ablation and resurfacing of the skin and for ablation and resurfacing of the skin for wrinkle treatment. Sublative RF's technology enables skin remodeling with minimal downtime. In fractional treatment, small damaged areas are created in the skin, accelerating tissue healing process after treatment.
- Sublime applicator, which is intended for non invasive wrinkles treatment. The applicator uses pulsed infrared light combined with RF energy for Deep Tissue Stimulation leading to skin tightening. Thermal stimulation of the deep dermis contributes to collagen enrichment and tissue remodeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (facial)
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 safety and efficacy of the eTwo Skin Treatment System was evaluated in the two cleared applicators that are part of this device. Syneron believes that clinical data is not required to determine the safety and efficacy of the eTwo Skin Treatment System.
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.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/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 font. The logo appears to be for a medical company.
OCT - 3 2011
510(K) SUMMARY
eTwo Skin Treatment System 510(k) Number K | | 0672
| Applicant's Name: | Syneron Medical Ltd.
Industrial Zone
Tavor Building
Yokneam Illit 20692
Israel
Tel: (972)73-244-2200
Fax: (972)73-244-2202 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite
31 Haavoda Street
Binyamina, Israel 30500
Tel (972)4-638-8837; Fax (972)4-638-0510
Yoram@qsitemed.com |
| Trade Name: | eTwo Skin Treatment System |
| Preparation Date: | March 07, 2011 |
| Classification: | Name: Electrosurgical cutting & coagulation d |
levice & accessories Product Code: GEI, OUH Regulation No: 21 CFR 878.4400, 21CFR 878.4810 Class: II Panel: General and Plastic Surgery
Device Description:
The eTwo skin treatment system is a mobile operating system combining two treatment applicators:
- . Sublative RF applicator, which is intended for dermatological procedures requiring ablation and resurfacing of the skin and for ablation and resurfacing of the skin for wrinkle treatment. Sublative RF's technology enables skin remodeling with minimal downtime. In fractional treatment, small damaged areas are created in the skin, accelerating tissue healing process after treatment.
1
Image /page/1/Picture/0 description: The image shows the logo for Syneron Medical LTD. The word "Syneron" is written in a stylized font, with the "S" being a unique, flowing design. Below "Syneron" is the text "Medical LTD" in a simpler, block-letter font.
●
Sublime applicator, which is intended for non invasive wrinkles treatment. The applicator uses pulsed infrared light combined with RF energy for Deep Tissue Stimulation leading to skin tightening. Thermal stimulation of the deep dermis contributes to collagen enrichment and tissue remodeling.
Intended Use Statement:
The eTwo Skin Treatment system is intended for dermatological procedures.
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."
Predicate Devices: Substantial equivalence to the following predicate devices is claimed:
| Device Name | 510k No | Date of Clearance |
|---|---|---|
| Syneron Matrix RF | ||
| Applicator | K090025 | Jan 8, 2010 |
| Syneron Polaris WR ST | ||
| Applicator | K053616 | Mar 14, 2006 |
| EndyMed Imagine TC Skin | ||
| Treatment System | K083461 | Jul 24, 2009 |
Performance Standards:
eTwo Skin Treatment System complies with:
- . EN 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems.
- . IEC 60601-1-2 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
- . ANSI AAMI 60601-2-2 safety of high frequency surgical equipment.
A detailed description appears in Section 14.
2
Image /page/2/Picture/0 description: The image contains the word "Syneron" in a stylized font. The letters are outlined in black, giving them a distinct appearance. The "S" is particularly unique, with a curved design that stands out from the rest of the word.
Medical LTD Summary of Clinical performance data:
The safety and efficacy of the eTwo Skin Treatment System was evaluated in the two cleared applicators that are part of this device. Syneron believes that clinical data is not required to determine the safety and efficacy of the eTwo Skin Treatment System.
3
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 depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Syneron, LTD % QSite Yoram Levy 31 Haavoda Street Binyamina, Israel 30500
Re: K110672
Trade/Device Name: eTwo Skin Treatment System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI. OUH Dated: September 4. 2011 Received: September 7, 2011
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.
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
OCT - 3 2311
4
Page 2 - Yoram Levy
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
y yours,
for
Melkerson
cin D
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the logo for Syneron Medical LTD. The word "Syneron" is written in a stylized font, with the "S" overlapping the "y". Below the word "Syneron" is the text "Medical LTD" in a bold, sans-serif font. The logo is simple and professional, and it is likely used to represent the company in its marketing materials.
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
eTwo Skin Treatment System
.
Indications for Use:
The eTwo Skin Treatment system is intended for dermatological procedures.
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."
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
sc
(part 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
Division Sign Off
(Div. sion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110672