(267 days)
Not Found
No
The summary describes a device that uses bipolar RF energy for skin resurfacing and ablation, with no mention of AI, ML, image processing, or any data-driven decision-making processes.
Yes
The device is intended for dermatological procedures requiring ablation and resurfacing of the skin, which is a therapeutic purpose. It creates micro-ablation points on the skin and provides a volumetric non-ablative heating effect in the dermis, affecting the body's structure and function for treatment.
No
The device is described as being "intended for dermatological procedures requiring ablation and resurfacing of the skin" and creating "micro-ablation points on the skin". It is a treatment handpiece, not collecting information or assessing a condition.
No
The device is a hardware handpiece that emits RF energy for skin treatment, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatological procedures requiring ablation and resurfacing of the skin." This is a direct treatment applied to the patient's skin.
- Device Description: The device emits bipolar RF energy to create micro-ablation points on the skin. This is a physical interaction with the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
The device is clearly intended for therapeutic and cosmetic procedures performed directly on the patient's skin, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Applicator 3 Fractional (A3F) is intended for dermatological procedures requiring ablation and resurfacing of the skin
Product codes
GEI
Device Description
Pollogen's Applicator 3 Fractional (A3F) is a treatment handpiece to be attached to the FDA cleared Pollogen's apollo™ system (K111026). The A3F tip emits bipolar RF energy that flows between electrodes to create micro-ablation points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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
Safety and efficacy of the Applicator 3 Fractional (A3F) was supported by performing histological evaluation study on porcine skin. The results of this study clearly indicate that the Applicator 3 Fractional (A3F) offers an effective, safe device for skin resurfacing.
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.
0
Pollogen™
510(K) SUMMARY
. Page 1 of (2)
Applicator 3 Fractional (A3F) 510(k) Number K122200
APR 1 8 2013
Pollogen Ltd. Applicant's Name: 6 Kaufman St. Gibor House, P.O.B. 50320 Tel Aviv ISRAEL 68012 Tel. (972)3-510-4110 Fax (972)3-510-4112
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: Applicator 3 Fractional (A3F)
Summary Preparation Date: July 18, 2012
Classification: Name: Electrosurgical, cutting & coagulation device & accessories Product Code: GEI Regulation No: 21 CFR 878.4400 Class: II Panel: General and Plastic Surgery
Device Description:
Pollogen's Applicator 3 Fractional (A3F) is a treatment handpiece to be attached to the FDA cleared Pollogen's apollo™ system (K111026).
The A3F tip emits bipolar RF energy that flows between electrodes to create micro-ablation points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis.
Applicator 3 Fractional (A3F) - 510k Submission
1
Pollogen™
Page 2 of 2
Intended Use Statement:
The Applicator 3 Fractional (A3F) is intended for dermatological procedures requiring ablation and resurfacing of the skin
Predicate Devices: Substantial equivalence to the following predicate device is claimed:
| Device Name | 510k No | Date of Clearance |
|---|---|---|
| Syneron Matrix RF | ||
| Applicator | K073572 | Sep 17, 2008 |
Performance Standards:
Applicator 3 Fractional (A3F) complies with
-
IEC 60601-1 Medical Electrical Equipment-Part 1: General . · Requirements for Safety. 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.
-
IEC 60601-2-2 Medical Electrical Equipment-Part 2: . Particular requirements for the safety of high frequency surgical equipment.
A detailed description appears in Section 14.
Summary of Pre-Clinical performance data:
safety and efficacy of the Applicator 3 Fractional The (A3F) was supported by performing histological evaluation study on porcine skin.
The results of this study clearly indicate that the Applicator 3 Fractional (A3F) offers an effective, safe device for skin resurfacing.
Applicator 3 Fractional (A3F) - 510k Submission
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 18, 2013
Pollogen, Ltd. % QSite Mr. Yoram Levy 31 Haavoda Street Binyamina 30500 Israel
Re: K122200
Trade/Device Name: Applicator 3 Fractional (A3F) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 20, 2013 Received: February 26, 2013
Dear Mr. 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
3
Page 2 - Mr. Yoram Levy
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/ResourcesforYou/Industry/default.htm.
Sincerely yours. FOR
Peter DRumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Pollogen"
INDICATIONS FOR USE STATEMENT
K122200 510(k) Number (if known):
Device Name:
Applicator 3 Fractional (A3F)
Indications for Use:
The Applicator 3 Fractional (A3F) is intended for dermatological procedures requiring ablation and resurfacing of the skin
Use X Prescription (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)
Joshua C. Nipper
FDA-S
For
(Division Sign-off) Division of General, Restorative and Neurological Devices 510(k) Number: K122200
Applicator 3 Fractional (A3F) - 510k Submission