(134 days)
Not Found
No
The device description mentions a microprocessor and user interface for parameter control, but there is no mention of AI, ML, image processing, or data sets for training or testing, which are typical indicators of AI/ML integration in medical devices.
Yes
The device is intended for non-invasive treatment of facial wrinkles and rhytids, which constitutes a therapeutic purpose.
No
The device is described as being for "non-invasive treatment of facial wrinkles and rhytids," indicating a therapeutic rather than diagnostic purpose. It does not mention any function for identifying, detecting, or monitoring a disease or condition.
No
The device description explicitly lists hardware components such as internal electronics, RF generator, treatment handpieces, and a reference electrode, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "non-invasive treatment of facial wrinkles and rhytids" in dermatologic and general surgical procedures. This describes a therapeutic or cosmetic treatment applied directly to the patient's body.
- Device Description: The description details a system that generates and applies radiofrequency (RF) energy to the skin. This is a physical intervention, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Iskra Medical Green IRF Prestige and Accessories are intended for use in dermatologic and general surgical procedures for non-invasive treatment of facial wrinkles and rhytids.
Product codes
GEI
Device Description
The Iskra Medical Green IRF Prestige system consists of a user interface, internal electronics controlled by microprocessor, RF generator, 2 treatment handpieces (small and large applicator), and reference electrode. The treatment parameters are selected and controlled via the touch screen.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070004, K072699, K033942, K040135, K053365, K051214
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
Image /page/0/Picture/0 description: The image shows the text "K 083590" in a handwritten style, with the word "Iskra Medical" appearing below the numbers. A logo is placed between the numbers and the company name. The text and logo are in black and white, and the image appears to be a close-up of a document or label.
APPENDIX 2
APR 1 7 2009
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
I. General Information
| Applicant: | Iskra Medical d.o.o.
Stegne 23, 1000 Ljubljana, Slovenia |
|-------------------|-------------------------------------------------------------|
| Contact Person: | Mojca Valjavec |
| Phone: | + 386 1 51 31 506 |
| Fax: | + 386 1 51 31 510 |
| Preparation Date: | 11-28-08 |
II. Device
| Device Trade Name: | Iskra Medical Green IRF Prestige |
|---|---|
| Common Name: | Electrosurgical Unit and Accessories |
| Classification Name: | Device, Electrosurgical Cutting and Coagulation |
| and Accessories (21 CFR 878.4400) |
III. Legally Marketed Predicate Devices
- . Alma Laser Accent RF System (K070004, K072699)
- . Thermage ThermaCool TC system (K033942, K040135, K053365)
- . Lumenis Aluma Skin Renewal system (K051214)
IV. Device Description
The Iskra Medical Green IRF Prestige system consists of a user interface, internal electronics controlled by microprocessor, RF generator, 2 treatment handpieces (small and large applicator), and reference electrode. The treatment parameters are selected and controlled via the touch screen.
V. Intended Use
The Iskra Medical Green IRF Prestige and Accessories are intended for use in dermatologic and general surgical procedures for non-invasive treatment of facial wrinkles and rhytids.
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VI. Rationale for Substantial Equivalence
The Iskra Medical Green IRF Prestige system shares the same indications for use, similar design and functional features with predicate devices, and thus it has been found to be substantially equivalent to the predicate devices.
VII. Summary
As the Iskra Medical Green IRF Prestige system is substantially equivalent with respect to indication for use, materials, method of operation and physical construction to the predicate devices, we believe it clearly meets the requirements for substantial equivalence.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Iskra Medical, d.o.o. % Ms. Mojca Valjavec Marketing & Sales Manager Stegne 23, SI-1000 Ljubliana SLOVENIA
APR 1 7 2009
Re: K083590
Trade/Device Name: ISKRA MEDICAL GREEN IRF PRESTIGE AND ACCESSORIES Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 18, 2009 Received: March 23, 2009
Dear Ms. Valjavec:
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 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 - Ms. Mojca Valjavec
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Melkerson
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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IskraMedical
APPENDIX 1
INDICATIONS FOR USE STATEMENT
K 083590 510(k) Number (if known):
Device Name:
ISKRA MEDICAL GREEN IRF PRESTIGE AND ACCESSORIES
Indications for Use:
Iskra Medical Green IRF Prestige and Accessories are intended for use in dermatologic and general surgical procedures for non-invasive treatment of facial wrinkles and rhytids.
Prescription Use X (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 CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | Page 1 of 1 | |
| Division of General, Restorative, and Neurological Devices | ||
| 510(k) Number | K083590 | |
| Traditional 510(k) Notification: | Appendix 1 |
Iskra Medical Green IRF Prestige and Accessories
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