PORTRAIT PSR3

K060948 · Rhytec Incorporated · GEI · Sep 5, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060948
• Device Name: PORTRAIT PSR3
• Applicant: Rhytec Incorporated
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Portrait PSR3 is indicated for treatment of the following dermatological conditions: - Treatment of wrinkles and rhytides . - . Superficial skin lesions - . Actinic Keratosis - . Viral Papillomata - . Seborrhoeic Keratosis

Device Story

Portrait PSR3 is an electrosurgical device for dermatological applications. It uses UHF energy to convert Nitrogen gas into plasma within a handpiece. The plasma emerges from the nozzle as individual pulses, delivering precisely controlled energy to the skin surface. This rapid heating provides predictable tissue effects for resurfacing and lesion treatment. The device is operated by a clinician in a clinical setting. The output is the plasma pulse itself, which the clinician directs onto the patient's skin to reduce wrinkles and treat specific skin lesions. The device benefits patients by providing a controlled method for skin rejuvenation and lesion removal.

Clinical Evidence

Clinical study included 10 subjects treated at 30 anatomical sites. Results showed significant improvement in three anatomic regions, with observed reductions in skin dyspigmentation and wrinkle severity in the neck, chest, and dorsum of the hands.

Technological Characteristics

Electrosurgical device; UHF energy source; Nitrogen gas conversion to plasma; handpiece-based delivery; precisely controlled energy pulses.

Indications for Use

Indicated for patients requiring treatment of wrinkles, rhytides, superficial skin lesions, actinic keratosis, viral papillomata, and seborrhoeic keratosis.

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

• Gyrus Medical, Inc. Plasma Skin Resurfacing (PSR) System (K041999)
• Thermage ThermaCool System (K053365, K052778, K021402, and K013639)

Submission Summary (Full Text)

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K060948

## 510(k) Summary for the Rhytec, Inc. Portrait PSR3

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This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

## 1. General Information

| Submitter: | Rhytec, Inc.<br>1000 Winter Street<br>Waltham, MA 02451 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell<br>O'Connell Regulatory Consultants, Inc.<br>5 Timber Lane<br>North Reading, MA 01864<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | March 31, 2006 |

2. Names

| Device Name: | Portrait PSR3 |
|----------------------|---------------------------------------------------------------------|
| Classification Name: | Electrosurgical cutting and coagulation device<br>Product Code: GEI |

3. Predicate Devices

The Portrait PSR3 is substantially equivalent to the Gyrus Medical, Inc. Plasma Skin Resurfacing (PSR) System (K041999) and the Thermage ThermaCool System (K053365, K052778, K021402, and K013639).

### 4. Device Description

The Rhytec, Inc. Portrait PSR3 is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts Nitrogen gas into plasma within the handpiece. The plasma emerges from the nozzle at the distal end of the handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up energy to the skin. Through the combination within the handpiece of precisely controlled energy and Nitrogen gas, individual plasma pulses are produced that will give predictable tissue effects.

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K060948

### 5. Indications for Use

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The Portrait PSR3 is indicated for treatment of the following dermatological conditions:

- Treatment of wrinkles and rhytides .
- . Superficial skin lesions
- . Actinic Keratosis
- . Viral Papillomata
- . Seborrhoeic Keratosis

# 6. Performance Data

A clinical study was conducted which included 10 subjects treated in 30 anatomical sites which showed significant improvement in each of the three anatomic regions observed. Reduction in skin dyspigmentation and wrinkle severity was observed in neck and chest skin and in the skin of the dorsum of the hands.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three horizontal lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP - 5 2006

Rhytec. Inc % Ms. Maureen O'Connell O'Connell Regulatory Consultants, Inc. 1000 Winter Street Waltham, Massachusetts 02451

Re: K060948

Trade/Device Name: Rhytec, Inc. Portrait PSR3 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting coagulation device and accessories Regulation Class: Class II Product Code: GEI Dated: August 7, 2006 Received: August 9, 2006

Dear Ms. O'Connell:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. Maureen O'Connell

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): _ K 060948

Device Name: Rhytec, Inc. Portrait PSR3

Indications for Use:

The Portrait PSR3 is indicated for treatment of the following dermatological conditions:

- Treatment of wrinkles and rhytides �
- Superficial skin lesions
- Actinic Keratosis
- Viral Papillomata
- Seborrhoeic Keratosis

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rob

(Division Sign-Off)

Division of Cenera' Restorative,

and Neurological Devices

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**510** Number /060928

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