SERENITY PRO PSF SYSTEM

K071943 · Inolase 2002, Ltd. · GEX · Aug 10, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071943
• Device Name: SERENITY PRO PSF SYSTEM
• Applicant: Inolase 2002, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 10, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Serenity Pro PSF™ System is an accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it.

Device Story

Serenity Pro PSF™ System is a pneumatic skin flattening accessory for laser or IPL hair removal devices. Device generates negative pressure (400-700 mbar) via a handpiece equipped with a sapphire window. Handpiece is positioned over treatment site; vacuum flattens skin, expelling blood from tissue. Laser/IPL beam is delivered through the transparent, thermally conductive sapphire window. Mechanical contact enhances light penetration and facilitates heat removal from skin, potentially reducing post-treatment erythema. Operated by clinicians in a clinical setting. Output is a physical state of the skin (flattened/blanched) to optimize photonic treatment delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pneumatic vacuum system (400-700 mbar). Handpiece features a sapphire window (thermally conductive, transparent). Class II device, product code GEX. Regulation 21 CFR 878.4810.

Indications for Use

Indicated for use as an accessory to legally marketed laser or intense pulsed light (IPL) systems for hair removal procedures.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Inolase Serenity PSF™ (Pneumatic Skin Flattening) System (K062589)

Submission Summary (Full Text)

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## 510(k) Summary

13 Giborei Israel St., PO Box 8497

Netanya (New Industrial Area)

K07/943

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

1. (b)

Manufacturer

Mfg. Phone:

Contact Person:

Address:

- George J. Hattub Submitter's 1. (a) Address: MedicSense, USA 291 Hillside Avenue Somerset, MA 02726
Inolase 2002, Ltd.

Israel, 42504

972-9-865-6750

Raphi Shavit, CEO

AUG 1 0 2007

- Date: June 30. 2007 2. Device & Laser Handpiece Accessory System (Class 2), Product Code GEX, Classification Name: 21 CFR 878.4810 - Tradename of device: Serenity Pro PSF™ System Inolase Serenity PSF™ (Pneumatic Skin Flattening) System (K062589) Predicate Device: 3. The Serenity Pro PSF™ System is a device which has the ability to produce a 4. Description: vacuum at a level of 400-700 mbar. Suction can be delivered through its handpiece, which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PSF system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment ervthema. 5. The Serenity PSF™ (Pneumatic Skin Flattening) System is an accessory for a Intended Use: compatible legally market Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface just prior to the administration of the treatment beam through it. દ. Comparison of Technological With respect to technology, the Serenity Pro PSF™ System is substantially Characteristics: equivalent to its predicate device in that it produces a pneumatic connection of the treatment site for the delivery of photonic treatment. A significant difference is the ability of its handpieces to manually or automatically produce a vacuum over the treatment site

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Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 0 2007

Inolase 2002, Ltd. % Medicsense, USA Mr. George J. Hattub Senior Staff Consultant 291 Hillside Avenue Somerset, Massachusetts 02726

Re: K071943

Trade/Device Name: Serenity Pro PSF " System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: July 10, 2007 Received: July 13, 2007

Dear Mr. Hattub:

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. George J. Hattub

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,

Mark A. Melkerson

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 071943

Device Name: Serenity Pro PSF™ System

Indications For Use: The Serenity Pro PSF™ System is an accessory for a compatible leqally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it.

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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark H. Millikan

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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510(k) Number