(77 days)
Not Found
No
The device description focuses on hardware components and a programmable logic controller (PLC) for operational and safety functions. There is no mention of AI, ML, image processing, or data sets for training/testing, which are typical indicators of AI/ML integration in medical devices.
Yes
The device is intended for use in "Dermatologic and General Surgical procedures" and its specific applicators are indicated for treating "mild to moderate facial wrinkles and rhytides" and for "ablation and resurfacing of the skin," which are therapeutic actions aimed at improving a cosmetic condition or repairing tissue.
No
The device description states its purpose is to provide RF energy for treatment (ablation, resurfacing, wrinkle reduction), not for diagnosing conditions.
No
The device description explicitly lists hardware components such as a user interface, PLC, RF power module, internal electronics, and treatment handpieces.
Based on the provided information, the Glow by EndyMed is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "Dermatologic and General Surgical procedures" and focuses on treating "facial wrinkles and rhytides" and "ablation and resurfacing of the skin." These are procedures performed directly on the patient's body.
- Device Description: The description details a non-invasive unit that delivers RF energy to the skin via handpieces. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Glow by EndyMed is a therapeutic device that applies energy to the body for treatment purposes.
N/A
Intended Use / Indications for Use
The Glow by EndyMed is a noninvasive device intended for use in Dermatologic and General Surgical procedures.
The TC applicator is indicated for mild to moderate facial wrinkles and rhytides.
The FSR applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin.
Product codes (comma separated list FDA assigned to the subject device)
GEI, OUH
Device Description
The EndyMed Glow is a non-invasive unit consists of a user interface, programmable logic controller (PLC), an RF power module, internal electronics, and treatment handpieces. The user interface allows the selection of treatment parameters by pressing on the treatment buttons; A LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety functions of the system.
The system is connected to one or two out of 2 TC handpieces with different size electrode areas for different treatment sites, or to a FSR handpiece.
The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at 1MHz frequency.
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.
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
PS 1 of 4
Section 2- 510(k) Summary
:
MAY - 8 2012
1
Image /page/1/Picture/0 description: The image contains the logo for EndyMed, a company specializing in 3DEEP technology. The logo features the company name in bold, sans-serif font, with the "TM" symbol next to "Med". Below the name, the tagline "THE 3DEEP COMPANY" is written in a smaller font. To the left of the company name, there is a pattern of dots arranged in a grid-like fashion.
120513 pg 2 of 4
510(K) SUMMARY
Glow by EndyMed
510(k) Number K
Applicant's Name: EndyMed Medical Ltd 7 Bareket Street, North Industrial Park, Caesarea, 30889 Israel Tel: (972)4-630-9100 Fax: (972)4-630-9101
Contact Person:
Yoram Levy, Qsite 31 Haavoda Street Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com
Trade Name: Glow by EndyMed
Preparation Date: January 30, 2012
Name: Electrosurgical, cutting & coagulation device Classification: & accessories Product Code: GEI. OUH Regulation No: 21 CFR 878.4400 Class: II Panel: General and Plastic Surgery
Device Description: The EndyMed Glow is a non-invasive unit consists of a user interface, programmable logic controller (PLC), an RF power module, internal electronics, and treatment handpieces. The user interface allows the selection of treatment parameters by pressing on the treatment buttons; A LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety functions of the system.
The system is connected to one or two out of 2 TC handpieces with different size electrode areas for different treatment sites, or to a FSR handpiece.
1-3
Glow by EndyMed - 510k Notification
2
::: EndyMed™
THE 3DEEP™ COMPANY
pg 3 of 4
The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at 1MHz frequency.
Intended Use Statement: The Glow by EndyMed is a noninvasive device intended for use in Dermatologic and General Surgical procedures.
The TC applicator is indicated for mild to moderate facial wrinkles and rhytides.
The FSR applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin.
Predicate Devices: Substantial equivalence to the following predicate devices is claimed:
| Device Name | 510k No | Date of Clearance |
|---|---|---|
| EndyMed Imagine TC Skin | ||
| Treatment System | K083461 | Jul 24, 2009 |
| EndyMed Fractional Skin | ||
| Resurfacing (FSR) | ||
| Applicator | K101510 | Feb 17, 2011 |
. Performance Standards:
.
Glow by EndyMed 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 (Electromagnetic compatibility (EMC) �
- . ANSI AAMI 60601-2-2 for safety of high frequency surgical equipment.
A detailed description appears in Section 14.
Summary of the technological characteristics of the Glow by EndyMed compared to the predicate devices
The Glow by EndyMed has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices.
The TC applicator has exactly the same RF technology characteristics as the EndyMed Imagine TC Skin Treatment System
1-4
Glow by EndyMed – 510k Notification •
3
.
.
pg 4 of 4
.
Image /page/3/Picture/2 description: The image shows the logo for EndyMed. The logo consists of a grid of dots on the left, followed by the word "EndyMed" in a bold, sans-serif font. Below the word "EndyMed" is the phrase "THE 3DEEP COMPANY" in a smaller font. The TM symbol is present next to the word "DEEP".
(K0834610) and the FSR applicator has the same fractional RF technology as the EndyMed Fractional Skin Resurfacing (FSR) Applicator (K101510)
:
.
ﺎ .
.
. .
·
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with flowing lines, representing the department's mission related to health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
EndyMed Medical, LTd % Yoram Levy 7 Bareket Street North Industrial Park Caesarea, 30889 Israel
MAY - 8 2012
Re: K120513
Trade/Device Name: Glow by EndyMed Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: OUH, GEI Dated: February 15, 2012 Received: February 21, 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mcan that FDA has made a determination that your device complies with other requirements of the Act
5
Page 2 - Yoram Levy
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 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Etnel Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Glow by EndyMed
Indications for Use:
The Glow by EndyMed is a noninvasive device intended for use in Dermatologic and General Surgical procedures.
The TC applicator is indicated for mild to moderate facial wrinkles and rhytides.
The FSR applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin.
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 Nourological Device 510(k) Number
Nailre de form na
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120513
1 - 1 Glow by EndyMed - 510k Notification