ISKRA MEDICAL GREEN IRF PRESTIGE

K083590 · Iskra Medical, D.O.O. · GEI · Apr 17, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083590
• Device Name: ISKRA MEDICAL GREEN IRF PRESTIGE
• Applicant: Iskra Medical, D.O.O.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The Iskra Medical Green IRF Prestige is an electrosurgical system for non-invasive facial wrinkle and rhytid treatment. The system comprises a microprocessor-controlled RF generator, a user interface with a touch screen, two treatment handpieces (small and large applicators), and a reference electrode. The device delivers radiofrequency energy to the skin to achieve its therapeutic effect. It is intended for use by clinicians in dermatologic and general surgical settings. The operator selects treatment parameters via the touch screen, which the internal electronics manage to control the RF output. The device provides a non-invasive alternative for skin rejuvenation, helping to improve the appearance of facial wrinkles.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, functional, and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Electrosurgical unit; RF generator; microprocessor-controlled; touch screen interface; two handpieces (small/large); reference electrode. Operates via RF energy delivery for non-invasive tissue treatment.

Indications for Use

Indicated for patients requiring non-invasive treatment of facial wrinkles and rhytids in dermatologic and general surgical procedures.

Regulatory Classification

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.

Predicate Devices

• Alma Laser Accent RF System (K070004, K072699)
• Thermage ThermaCool TC system (K033942, K040135, K053365)
• Lumenis Aluma Skin Renewal system (K051214)

Submission Summary (Full Text)

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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.<br>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<br>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.

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## 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 [phone]. 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 [phone]. 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 [phone] or [phone] 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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