(29 days)
Not Found
No
The summary describes a radiofrequency device for wrinkle treatment and does not mention any AI or ML components or functionalities.
No.
The device is indicated for non-ablative treatment of mild to moderate facial wrinkles, which is generally considered an aesthetic treatment rather than a therapeutic one for a disease or medical condition.
No
The device is described as a "Non-Ablative Wrinkle Treatment System" and is indicated for the "non-ablative treatment of mild to moderate facial wrinkles and rhytids." Its function is therapeutic (treatment), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states it is a "hand-held, non-ablative wrinkle treatment handpiece available with various size electrode end effectors and a detachable cable," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "non-ablative treatment of mild to moderate facial wrinkles and rhytids." This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a "hand-held, non-ablative wrinkle treatment handpiece" that uses radiofrequency energy. This is consistent with a device used for a physical treatment, not for analyzing biological samples.
- Lack of IVD characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, the Pellevé Non-Ablative Wrinkle Treatment System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pellevé Non-Ablative Wrinkle Treatment System is indicated for the non-ablative treatment of mild to moderate facial wrinkles and rhytids.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The device is a hand-held, non-ablative wrinkle treatment handpiece available with various size electrode end effectors and a detachable cable. The device is activated using a hand or footswitch based on user preference and is used with the Ellman radiofrequency generators labeled for the treatment of wrinkles and rhytides. The radiofrequency generator operates 4 mHz and is used in the CUT or PELLEVE mode for non-ablative wrinkle treatments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
None submitted
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
K132665
510(K) Summary
This 510(K) Summary of safety and effectiveness for the Pellevé Non-Ablative Wrinkle Treatment System is submitted in accordance with the requirements of the SMDA 1990 and FDA guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Ellman International |
|---|---|
| Address: | Ellman International |
| 400 Karin Lane | |
| Hicksville, NY 11801 | |
| Contact Person: | Alison Sathe |
| Telephone: | 513-658-8960 |
| asathe@ellman.com | |
| Preparation Date: | August 21, 2013 |
| Device Trade Name: | Pellevé Non-Ablative Wrinkle Treatment System |
| Common Name: | Electrosurgical, cutting & coagulation & accessories |
| Classification Name: | Electrosurgical, cutting & coagulation & accessories |
| GEI, 878.4400 | |
| Legally Marketed Predicate | |
| Device(s): | Pellevé Non-Ablative Wrinkle Treatment System |
Device Description:
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..............................................................................................................................................................................
The device is a hand-held, non-ablative wrinkle treatment handpiece available with various size electrode end effectors and a detachable cable. The device is activated using a hand or footswitch based on user preference and is used with the Ellman radiofrequency generators labeled for the treatment of wrinkles and rhytides. The radiofrequency generator operates 4 mHz and is used in the CUT or PELLEVE mode for non-ablative wrinkle treatments.
Intended Use:
The device has been cleared pursuant to K102698 for the following Indications For Use: Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV.
Rationale presented herein is provided to amend the indication for use to: Non-ablative treatment of mild to moderate facial wrinkles and rhytids
1
The basis for this rationale is the system utilization of radiofrequency (RF) energy. RF interaction with tissue is based on impedance rather than melanin therefore skin phototype does not affect RF treatments.
Technological Characteristics:
The Pellevé Non-Ablative Wrinkle Treatment System has the same technological characteristics as the predicate device.
Performance Data: None submitted
Substantial Equivalence:
The Pellevé Non-Ablative Wrinkle Treatment System has the same principles of operation and technological characteristics as the predicate. The modifications for use raises no new issues of safety or effectiveness. Thus, Pellevé Non-Ablative Wrinkle Treatment System is substantially equivalent to the predicate.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
September 25, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
Ellman International, Incorporated Ms. Alison Sathe Director of Regulatory and Clinical Affairs 400 Karin Lane Hicksville, New York 11801
Re: K132665
Trade/Device Name: Pellevé Non-Ablative Wrinkle Treatment System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagniation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 23, 2013 Received: September 3, 2013
Dear Ms. Sathe:
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
3
Page 2 - Ms. Alison Sathe
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,
Neil R Ogden===
2013.10.16 12:37:17 -04'00'
For Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):__ K132665
Pellevé Non-Ablative Wrinkle Treatment System Device Name:
Indications for Use:
The Pellevé Non-Ablative Wrinkle Treatment System is indicated for the non-ablative treatment of mild to moderate facial wrinkles and rhytids.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
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For MXM (Division Sign-off) Division of Surgical Devices 510(k) Number K132665
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