PORTRAIT STAND-OFF

K072394 · Rhytec Incorporated · GEI · Sep 12, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072394
• Device Name: PORTRAIT STAND-OFF
• Applicant: Rhytec Incorporated
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 12, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Portrait® PSR3 System is intended 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 a generator to convert nitrogen gas into plasma within a handpiece. The plasma emerges from a nozzle and is directed onto the skin, causing rapid heating through energy transfer. The device is used by clinicians in a clinical setting. This modification introduces a reusable/disposable stand-off distance gauge (available in 5 mm and 25 mm sizes) to assist the user in maintaining the correct distance between the nozzle and the patient's skin, replacing the non-contacting LED targeting ring. The gauge ensures consistent energy delivery and predictable tissue effects.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Electrosurgical cutting and coagulation device. Materials: Ultem 1000 and Accura® DuraForm™ PA Polyamide (nylon). Energy source: UHF energy generator converting nitrogen gas to plasma. Form factor: Handpiece with detachable nozzle and stand-off distance gauge (5 mm and 25 mm).

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

• Portrait® PSR3 (K071786)

Reference Devices

• Candela Gentle YAG Laser System

Submission Summary (Full Text)

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Ko72394

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### 510(k) Summary

## For the Rhytec, Inc. Portrait® PSR3

# SEP 1 2 2007

#### General Information

Submitter:

Rhytec, Inc. 130 Turner Street Building Two Waltham, MA 02453

Contact Person

Robert Zoletti Rhytec, Inc. 130 Turner Street Building Two Waltham, MA 02543 Telephone: [phone] Email: [e-mail]

Summary Preparation Date: August 3, 2007

#### Names

Portrait® PSR3 System Trade Name: Classification Name: Electrosurgical cutting and coagulation device Product Code: GEI

#### Legally Market Predicate Devices

K071786 Portrait® PSR3

#### Device Description

The Rhytec, Inc. Portrait® PSR3 System is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts itrogen 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 predicy able

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K072394

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tissue effects. The detachable Nozzle Stand-off (distance gauge) assists the user in maintaining the proper distance between the Nozzle and the skin.

The modification is a reusable/disposable Standoff distance gauge accessory to the Portrait® PSR3 system.

#### Indications for Use Statement

The Portrait® PSR3 System is intended for treatment of the following dermatological conditions:

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

The indications are unchanged from K071886.

#### Technological Characteristics

The Stand-off is provided in two sizes: 5 mm and 25 mm. Materials include Ultem 1000 and Accura® DuraForm™ PA Polyamide (nylon). It is used in place of the noncontacting LED targeting ring to establish the distance between the Nozzle and the patient's skin.

#### Substantial Equivalence Comparison

The Stand-off is equivalent to the current non-contacting optical (LED) targeting system. It also provides the equivalent function of the distance gauges provided with the Candela Gentle YAG Laser System.

#### Clinical and Non-Clinical Data

The Stand-off was bench tested to assure usability and function.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2007

Rhytec, Inc. % Mr. Robert Zoletti Director, Regulatory Affairs and Quality 130 Turner Street Building Two Waltham, Massachusetts 02543

Re: K072394

Trade/Device Name: Rhytec, Inc. Portrait® PSR3 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 24, 2007 Received: August 27, 2007

Dear Mr. Zoletti:

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

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Page 2 - Mr. Robert Zoletti

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.

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,

P. N. M.

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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# K072394

#### Indications for Use

510(k) Number (if known): _

Device Name: __ Rhytec, Inc. Portrait® PSR3 ...

The Portrait® PSR³is indicated for treatment of the following dermatological conditions:

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

Indications for Use are unchanged from K071786

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(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)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | /6072359 |
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