(107 days)
No
The device description focuses on hardware components and user-activated controls, with no mention of AI/ML terms or functionalities.
Yes
The device is described as a "Non-ablative treatment of mild to moderate facial wrinkles and rhytides," indicating its use for therapeutic purposes (treating a medical condition like wrinkles/rhytides).
No
The device is described as a "Non-ablative treatment of mild to moderate facial wrinkles and rhytides," indicating a therapeutic purpose rather than a diagnostic one.
No
The device description explicitly states it is a hand-held handpiece with electrodes and a cord, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The description clearly states this device is a "hand-held, non-ablative wrinkle treatment handpiece" that uses radio-frequency energy applied to the skin for treating wrinkles.
- Intended Use: The intended use is "Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV." This is a therapeutic treatment applied directly to the patient's skin, not a diagnostic test performed on a sample.
The device's function and intended use are entirely focused on treating a condition on the body, not diagnosing a condition by analyzing a sample from the body.
N/A
Intended Use / Indications for Use
The Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV.
Product codes
GEI
Device Description
The device is a hand-held, non-ablative wrinkle treatment handpiece available with various size electrode end effectors and a detachable cord. The electrode is spring mounted into the handle. All materials used in the manufacture of the device are suitable for the use in the device and are the same materials used in the predicate product. As with the predicated device, the device is activated using a hand or footswitch based on user preference and is intended for use with the Ellman Radio-Frequency generators (K082834) labeled for the treatment of wrinkles and rhytides.
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
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
All appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. In all instances, the Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System functioned as intended and in conformance with anticipated results.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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14102698 510(k) Summary
General Information
| Date Prepared | 10/25/2010 |
|---|---|
| Classification | Class II, CFR 878.4400 |
| Product Code GEI | |
| Common Name | Electrosurgical, cutting & coagulation & accessories |
| Trade Name | Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System |
| Submitter | Ellman International |
| 3333 Royal Ave | |
| Oceanside, NY 11572 | |
| Contact Information | Mr. Jonathan Achenbach |
| Sr. Dir. R&D, Clinical & Regulatory Affairs | |
| Ph: 516-594-3333 | |
| Fax: 516-267-6750 |
Intended Use
The Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV.
Predicate Devices
Ellman Non Ablative Wrinkle Treatment System (K082834, K102368, K101967) manufactured by Ellman International
Technological Characteristics
The device is a hand-held, non-ablative wrinkle treatment handpiece available with various size electrode end effectors and a detachable cord. The electrode is spring mounted into the handle. All materials used in the manufacture of the device are suitable for the use in the device and are the same materials used in the predicate product. As with the predicated device, the device is activated using a hand or footswitch based on user preference and is intended for use with the Ellman Radio-Frequency generators (K082834) labeled for the treatment of wrinkles and rhytides.
Substantial Equivalence
The Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System is as safe and effective as the Ellman Non Ablative Wrinkle Treatment System. The Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System has the same indication for use, technological characteristics, and principles of operation as its predicate device. The minor technological improvements made to the device from the previous generation predicate device do not alter the fundamental scientific
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technology of the device and raise no new issues of safety or effectiveness. Thus, the Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System is substantially equivalent.
Performance Data
All appropriate testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests. In all instances, the Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System functioned as intended and in conformance with anticipated results.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping, curved lines, which is the department's official emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ellman International Inc. % Mr. Jonathan Achenbach 3333 Royal Ave. Oceanside, NY 11572
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Re: K102698
Trade Name: Pellevé Glidesafe Non-Ablative Wrinkle Treatment System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 29, 2010 Received: January 3, 2011
Dear Mr. Achenbach:
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 Foond, Or ug 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.
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 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.
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Page 2 - Mr. Jonathan Achenbach
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/ucm I I S800.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 Presi 807.97). For questions regarding the reporting of adverse events under the MDR regulation (1 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,
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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Ellman International
"INDICATIONS FOR USE" Statement
KIO2698 510(k) Number (if known):
Device Name: Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System
The Device has the following "Indications for Use":
Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV
Prescription Use X
OR
Over-The Counter Use_
(per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 1-2-96)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102698